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NCT03215030 · REGISTRY CONDITION SEARCH

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2026-01-29

The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)

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outcome · POSTED

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs

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outcome · POSTED

Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)

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outcome · POSTED

Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE

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outcome · POSTED

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay

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outcome · POSTED

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions

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outcome · POSTED

Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions

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outcome · POSTED

Part 1: Percentage of Participants With Clinically Significant Laboratory Values

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outcome · POSTED

Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

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outcome · POSTED

Part 2: Overall Response Rate (ORR)

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outcome · POSTED

Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)

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outcome · POSTED

Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

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outcome · POSTED

Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa

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outcome · POSTED

Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa

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outcome · POSTED

Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

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outcome · POSTED

Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa

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outcome · POSTED

Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa

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outcome · POSTED

Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa

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outcome · POSTED

Part 1: CL: Clearance for Modakafusp Alfa

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outcome · POSTED

Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa

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outcome · POSTED

Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit

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outcome · POSTED

Part 1: Overall Response Rate (ORR)

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outcome · POSTED

Parts 1 and 2: Clinical Benefit Rate (CBR)

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outcome · POSTED

Parts 1 and 2: Disease Control Rate (DCR)

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outcome · POSTED

Parts 1, 2, and 3: Duration of Response (DOR)

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outcome · POSTED

Parts 1 and 2: Time to Response

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outcome · POSTED

Parts 1, 2, and 3: Progression Free Survival (PFS)

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outcome · POSTED

Parts 2 and 3: Overall Survival (OS)

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outcome · POSTED

Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa

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outcome · POSTED

Part 2: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

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outcome · POSTED

Part 2: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa

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outcome · POSTED

Part 2: λz: Terminal Disposition Rate Constant for Modakafusp Alfa

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outcome · POSTED

Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa

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outcome · POSTED

Part 2: CL: Clearance for Modakafusp Alfa

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outcome · POSTED

Part 2: Vss: Volume of Distribution at Steady State for Modakafusp Alfa

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outcome · POSTED

Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa

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outcome · POSTED

Part 3: Objective Response Rate (ORR) by Investigator Assessment

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outcome · POSTED

Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment

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outcome · POSTED

Part 3: Duration of Clinical Benefit

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outcome · POSTED

Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment

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outcome · POSTED

Part 3: Duration of Disease Control

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outcome · POSTED

Part 3: Time to Progression (TTP) by IRC and Investigator Assessment

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outcome · POSTED

Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

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outcome · POSTED

Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR

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outcome · POSTED

Part 3: Percentage of Participants With Treatment -Emergent Adverse Events (TEAEs)

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outcome · POSTED

Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs)

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outcome · POSTED

Part 3: Percentage of Participants With Clinically Significant Laboratory Values

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outcome · POSTED

Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status

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outcome · POSTED

Part 3: Health Care Utilization: Length of Hospital Stays

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outcome · POSTED

Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit

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outcome · POSTED

Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter

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outcome · POSTED

Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: For Parts 1 and 2: 1\. Has MM defined by the IMWG criteria with evidence of disease progression and: * In need of additional myeloma therapy as determined by the investigator. * Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug \[IMiD\], a proteasome inhibitor \[PI\], an alkylating agent, and/or an anti-CD38 as single agents or in combination). * Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD. For Part 3: 1. Has MM defined by the IMWG criteria with evidence of disease progression and: * In need of additional myeloma therapy as determined by the investigator. * Has previously received at least 3 lines of myeloma therapy. * Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide \[thalidomide excluded\]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible. 2. For participants in Part 2 and 3 only: Measurable disease is defined as : 1. Serum M-protein ≥500 mg/dL (≥5 g/L) 2. Urine M-protein ≥200 mg/24 hours. 3. Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal. 3. During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to \[≥ \] 10 percent \[%\]) and/or plasmacytoma (≥1 centimeter \[cm\] in diameter) detected by physical examination or imaging. 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. Exclusion Criteria: For Parts 1 and 2: 1. Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL). 2. Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression. 3. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline. 4. Has clinical signs of central nervous system involvement of MM. For Part 3: * Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. * In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received Modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 1 (Dose Escalation) Schedule A
    type
    EXPERIMENTAL
  2. description
    Participants received Modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 1 (Dose Escalation) Schedule B
    type
    EXPERIMENTAL
  3. description
    Participants received Modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 1 (Dose Escalation) Schedule C
    type
    EXPERIMENTAL
  4. description
    Participants received Modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 1 (Dose Escalation) Schedule D
    type
    EXPERIMENTAL
  5. description
    Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
    type
    EXPERIMENTAL
  6. description
    Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Dexamethasone
    label
    Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
    type
    EXPERIMENTAL
  7. description
    Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
    type
    EXPERIMENTAL
  8. description
    Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Dexamethasone
    label
    Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
    type
    EXPERIMENTAL
  9. description
    Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 3 (Dose Extension): Modakafusp Alfa 120 mg
    type
    EXPERIMENTAL
  10. description
    Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Part 3 (Dose Extension): Modakafusp Alfa 240 mg
    type
    EXPERIMENTAL
  11. description
    Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Japan Lead-in: Modakafusp Alfa 60 mg
    type
    EXPERIMENTAL
  12. description
    Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
    intervention Names
    1. Drug: Modakafusp alfa
    label
    Japan Lead-in: Modakafusp Alfa 120 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Japan Lead-in: Modakafusp Alfa 120 mg
    2. Japan Lead-in: Modakafusp Alfa 60 mg
    3. Part 1 (Dose Escalation) Schedule A
    4. Part 1 (Dose Escalation) Schedule B
    5. Part 1 (Dose Escalation) Schedule C
    6. Part 1 (Dose Escalation) Schedule D
    7. Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
    8. Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
    9. Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
    10. Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
    11. Part 3 (Dose Extension): Modakafusp Alfa 120 mg
    12. Part 3 (Dose Extension): Modakafusp Alfa 240 mg
    description
    Modakafusp alfa intravenous infusion.
    name
    Modakafusp alfa
    other Names
    1. TAK-573
    2. TEV-48573
    type
    DRUG
  2. arm Group Labels
    1. Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
    2. Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
    description
    Dexamethasone.
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
272
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
    measure
    Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
    time Frame
    Up to 54.3 months in Part 1
  2. description
    DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
    measure
    Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
  3. description
    An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs
    time Frame
    Up to 54.3 months in Part 1
  4. description
    AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to nearest decimal.
    measure
    Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)
    time Frame
    Up to approximately 54.3 months in Part 1
  5. description
    An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE
    time Frame
    Up to 54.3 months in Part 1
  6. description
    Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay
    time Frame
    Up to 54.3 months in Part 1
  7. description
    Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions
    time Frame
    Up to 54.3 months in Part 1
  8. description
    Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions
    time Frame
    Up to 54.3 months in Part 1
  9. description
    Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
    measure
    Part 1: Percentage of Participants With Clinically Significant Laboratory Values
    time Frame
    Up to 54.3 months in Part 1
  10. description
    Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.
    measure
    Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
    time Frame
    Up to 54.3 months in Part 1
  11. description
    ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response \[sCR\] + complete response \[CR\] + very good partial response \[VGPR\] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
    measure
    Part 2: Overall Response Rate (ORR)
    time Frame
    Up to 34.7 months in Part 2
  12. description
    ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Scr: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
    measure
    Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)
    time Frame
    Up to 20.5 months in Part 3
secondary Outcomes
  1. description
    Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for \>7 consecutive days; Grade 4 thrombocytopenia for \>14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing \>2-week delay in the next scheduled infusion before the initiation of Cycle 2 were considered a DLT. Percentages were rounded off to the nearest decimal.
    measure
    Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
    time Frame
    Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
  2. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
    time Frame
    Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
  3. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
    time Frame
    Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
  4. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
    measure
    Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  5. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  6. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
    measure
    Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  7. description
    As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  8. description
    Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: CL: Clearance for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  9. description
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
    measure
    Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
    time Frame
    Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
  10. description
    ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal.
    measure
    Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit
    time Frame
    Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
  11. description
    ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. Percentages were rounded off to the nearest decimal.
    measure
    Part 1: Overall Response Rate (ORR)
    time Frame
    Up to 54.3 months in Part 1
  12. description
    The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
    measure
    Parts 1 and 2: Clinical Benefit Rate (CBR)
    time Frame
    Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Full study description
brief Summary
The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
detailed Description
The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts: Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below: * Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg * Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD * Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD * Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD * Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg * Part 3 (Dose Extension): Modakafusp alfa 120 mg * Part 3 (Dose Extension): Modakafusp alfa 240 mg The Part 1 (Dose Escalation) portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of modakafusp alfa starting at 0.001 mg/kg for dose limiting toxicity (DLT) evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Part 2. The Part 2 (Dose Expansion) will further assess the safety profile of modakafusp alfa and its efficacy at MTD or OBD. For Part 3 (Dose Extension) participants will be randomized 1:1 to receive single-agent modakafusp alfa 120 mg or 240 mg Q4W. Parts 1 and 2 will be conducted at multiple centers in the United States. Part 3 will be conducted worldwide. The maximum treatment duration in this study is up to 12 months (Parts 1 and 2) or until disease progression (Part 3) and overall time to participate in the study is approximately up to 90 months. Participants with clinical benefit may continue treatment after sponsor approval.
Source references
references
  1. citation
    Holstein SA, Atrash S, Mian H, Dimopoulos MA, Schjesvold F, Popat R, Shah N, Gatt ME, Gocke CB, Frenzel L, Touzeau C, Beksac M, Manier S, Magen H, Travis P, Nadeem O, Suryanarayan K, Li C, Li S, Nelson A, Cherepanov D, Parot X, Vogl DT. A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma. Blood. 2025 Aug 28;146(9):1051-1064. doi: 10.1182/blood.2024027873.
    pmid
    40279508
    type
    DERIVED
  2. citation
    Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson D, Chaudry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins S, Parot X, Kaufman JL. Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma. Blood. 2025 Feb 27;145(9):944-955. doi: 10.1182/blood.2024026124.
    pmid
    39630057
    type
    DERIVED
Source notices and limitations
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