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NCT05556616 · REGISTRY CONDITION SEARCH

A Study of Modakafusp Alfa in Adult Participants With 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
Status at capture
TERMINATED
Registry last update
2026-01-29

The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. 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. Participants will be given modakafusp alfa 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

Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)

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outcome · NOT POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · NOT POSTED

Duration of Response (DOR)

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outcome · NOT POSTED

Groups 2 and 3: Overall Survival (OS)

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outcome · NOT POSTED

Groups 2 and 3: Time to Progression (TTP)

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outcome · NOT POSTED

Groups 2 and 3: Time to Next Treatment (TTNT)

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outcome · POSTED

Groups 2 and 3: Disease Control Rate (DCR)

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outcome · NOT POSTED

Groups 2 and 3: Event-free Survival (EFS)

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outcome · NOT POSTED

Groups 2 and 3: Time to Response (TTR)

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outcome · POSTED

Group 1: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5

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outcome · POSTED

Groups 2 and 3: Percentage of Participants With MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator

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outcome · POSTED

Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity

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outcome · POSTED

Group 2 and 3: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5

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outcome · POSTED

Groups 2 and 3: Duration of MRD Negativity Status at a Sensitivity Threshold of 10^-5 in Participants Achieving MRD Negativity

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outcome · NOT POSTED

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibody (NAb)

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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: 1. Group 1 (MM maintenance: modakafusp alfa/lenalidomide) only must have: 1. MM based on standard IMWG diagnostic criteria. 2. Undergone autologous stem cell transplantation (ASCT) for the treatment of MM within 12 months of the start of induction therapy and completed ASCT within 180 days before enrollment- (regardless of the lines of treatment).Consolidation cycles are allowed. Tandem transplant is allowed. 3. Not started lenalidomide maintenance before enrollment. Time to initiation of maintenance therapy: participants may start maintenance therapy as early as 60 days after transplantation and up to 180 days after transplantation or consolidation. 4. MRD positive ( after ASCT (MRD assessed at a threshold of 10\^-5 by local standard-of-care (SOC) methods or central assessment, if a prior local MRD assessment had not been performed). 5. No prior progression after initial therapy (at any time before starting maintenance). Participants whose induction therapy was changed due to suboptimal response or toxicity will be eligible if they do not meet criteria for progression. In addition, no more than 2 regimens will be allowed before ASCT, excluding dexamethasone alone. 6. No prior allogeneic hematopoietic stem cell transplant or solid organ transplant. 7. Recovered to Grade less than or equal to (\<=) 1 ASCT-related toxicities from the reversible effects of ASCT (except for alopecia and amenorrhea). MM based on standard IMWG diagnostic criteria. 2. Groups 2 and 3 (RRMM doublets and RRMM triplets) must have: 1. Measurable disease, defined as at least 1 of the following: * Serum M-protein \>=0.5 g/dL (\>=5 g/L) on serum protein electrophoresis (SPEP). * Urine M-protein \>=200 mg/24 hours on urine protein electrophoresis (UPEP). * Serum free light chain (FLC) assay result with an involved FLC level \>=10 mg/dL (\>=100 mg/L), provided the serum FLC ratio is abnormal (per IMWG criteria). 2. A confirmed diagnosis of MM according to International Myeloma Working Group (IMWG) criteria with documented disease progression in need of additional therapy as determined by the investigator. 3. For Group 2 RRMM doublet arms only: Participants who have received at least 3 prior lines of antimyeloma therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory drug (IMiD) and 1 anti-CD38 monoclonal antibody (mAb) drug, or who are triple refractory to a PI, and IMiD, and an anti-CD38 mAb drug regardless of the number of prior line(s) of therapy. d. For Group 3 RRMM triplet arms only: Participants who have received 1 to 3 prior lines of antimyeloma therapy including at least 1 PI and, 1 IMiD, and who are not refractory to the combination partners. e) For anti-CD38 arms, forced expiratory volume in 1second (FEV1) \>=50% predicted by pulmonary function testing. 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening 4. Has adequate organ function at screening as determined by the laboratory values required for enrollment: Absolute neutrophil count (ANC) \>=1000 per cubic millimeter (/mm\^3) (or \>=1\*10\^9/L); Platelets \>=75,000/mm\^3 (\>=75\*10\^9/L); Hemoglobin \>=8.0 g/dL; estimated creatinine clearance \>=30 mL/min (Cockcroft-Gault formula); Total serum bilirubin \<=2.0\*Upper limit of normal (ULN); an exception for participants with Gilbert's syndrome may be granted after discussion with the sponsor; Liver transaminases (alanine aminotransferase \[ALT\])/aspartate aminotransferase \[AST\]) \<=3.0\*ULN. 5. Has recovered from adverse reactions to prior myeloma treatment or procedures (example, chemotherapy, immunotherapy, radiation therapy) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade \<=1 or baseline treatment or have the toxicity established as sequela, except for sensory or motor neuropathy, which should have recovered to Grade \<=2 or baseline; ; (Grade 1 for the bortezomib arm). Exclusion criteria: 1. Currently participating in another MM interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) throughout the duration of this study. 2. Received previous treatment with modakafusp alfa. 3. Has a diagnosis of primary amyloidosis, Waldenström disease, monoclonal gammopathy of undetermined significance or smoldering MM per IMWG criteria or standard diagnostic criteria, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), lymphoplasmacytic lymphoma. 4. Has been diagnosed with another 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 and that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years. 5. Has evidence of central nervous system (CNS) involvement and/or meningeal involvement due to MM exhibited during screening. 6. Has a known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the modakafusp alfa formulation or to the study combination agents, the study medications, their analogs, or excipients in the various formulations of any agent per the prescribing information. 7. Is 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 and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and, a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. 8. Has a known history of seropositivity for HIV. 9. Has a known history of seropositivity for hepatitis C (anti-hepatitis C virus \[HCV\] antibody positive or anti-hepatitis C virus-RNA quantitation positive). Exception: Participants with a sustained virologic response with undetectable HCV RNA level at least 12 weeks after completion of antiviral therapy. 10. For bortezomib arms: participants received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization. 11. The participant has a chronic condition requiring the use of systemic corticosteroids \>10 mg/dL of prednisone or equivalent, in addition to any required corticosteroids for the treatment of MM. 12. Has a QTcF (QT interval corrected with Fridericia correction method \>480 millisecond (ms) (Grade \>=2).
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 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Lenalidomide
    label
    Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
    type
    EXPERIMENTAL
  2. description
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Pomalidomide
    label
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
    type
    EXPERIMENTAL
  3. description
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Carfilzomib
    label
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
    type
    EXPERIMENTAL
  4. description
    Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Bortezomib
    label
    Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
    type
    EXPERIMENTAL
  5. description
    Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Bortezomib
    3. Drug: Pomalidomide
    label
    Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Bortezomib
    type
    EXPERIMENTAL
  6. description
    Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Bortezomib
    3. Drug: Pomalidomide
    label
    Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
    type
    EXPERIMENTAL
  7. description
    Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
    intervention Names
    1. Drug: Modakafusp alfa
    2. Drug: Daratumumab
    3. Drug: Pomalidomide
    label
    Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
    2. Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Bortezomib
    3. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
    4. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
    5. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
    6. Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
    7. Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
    description
    Modakafusp alfa intravenous infusion.
    name
    Modakafusp alfa
    other Names
    1. TAK-573
    type
    DRUG
  2. arm Group Labels
    1. Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
    description
    Lenalidomide capsules orally.
    name
    Lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Bortezomib
    2. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
    3. Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
    description
    Bortezomib injection subcutaneously.
    name
    Bortezomib
    type
    DRUG
  4. arm Group Labels
    1. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
    description
    Carfilzomib intravenous infusion.
    name
    Carfilzomib
    type
    DRUG
  5. arm Group Labels
    1. Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
    description
    Daratumumab injection subcutaneously.
    name
    Daratumumab
    type
    DRUG
  6. arm Group Labels
    1. Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Bortezomib
    2. Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
    3. Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
    4. Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
    description
    Pomalidomide capsules orally.
    name
    Pomalidomide
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
15
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions.
    measure
    Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    Cycle 1 (Cycle length is 28 days)
  2. 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 was 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
    Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
    time Frame
    Up to 16.7 months
secondary Outcomes
  1. description
    PFS was defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD was determined by International Myeloma Working Group (IMWG) criteria. PD: increase of ≥25 percent (%) from lowest response value in any one or more of the following: serum M-component increase ≥0.5 gram per deciliter (g/dL) or urine M-component increase ≥200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
    measure
    Progression Free Survival (PFS)
    time Frame
    Up to 16.7 months
  2. description
    ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of study no participants were enrolled in Group 2 Arm 4: modakafusp alfa+bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
    measure
    Overall Response Rate (ORR)
    time Frame
    Up to 16.7 months
  3. description
    DOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
    measure
    Duration of Response (DOR)
    time Frame
    Up to 16.7 months
  4. description
    OS was defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.
    measure
    Groups 2 and 3: Overall Survival (OS)
    time Frame
    Up to 16.7 months
  5. description
    TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
    measure
    Groups 2 and 3: Time to Progression (TTP)
    time Frame
    Up to 16.7 months
  6. description
    TTNT was defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
    measure
    Groups 2 and 3: Time to Next Treatment (TTNT)
    time Frame
    Up to 16.7 months
  7. description
    DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
    measure
    Groups 2 and 3: Disease Control Rate (DCR)
    time Frame
    Up to 16.7 months
  8. description
    EFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
    measure
    Groups 2 and 3: Event-free Survival (EFS)
    time Frame
    Up to 16.7 months
  9. description
    TTR was defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
    measure
    Groups 2 and 3: Time to Response (TTR)
    time Frame
    Up to 16.7 months
  10. description
    Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who achieved MRD negative status in the MRD-evaluable analysis set.
    measure
    Group 1: Percentage of Participants With MRD Negativity Status at a Threshold of 10^-5
    time Frame
    At 6 months, 1 year, and 2 years after the start of treatment
  11. description
    Rate of MRD negativity CR status a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
    measure
    Groups 2 and 3: Percentage of Participants With MRD Negativity CR Status at a Threshold of 10^-5 in Participants Achieving CR Assessed by the Investigator
    time Frame
    Up to 2 years after CR confirmation
  12. description
    Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
    measure
    Duration of MRD Negativity Status at a Threshold of 10^-5 in Participants Achieving MRD Negativity
    time Frame
    Up to 2 years after treatment
Full study description
brief Summary
The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. 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. Participants will be given modakafusp alfa through a vein.
detailed Description
The drug being tested in this study is called modakafusp alfa (TAK-573). The study will evaluate the safety, tolerability and determine the recommended dose of modakafusp alfa in combination with lenalidomide in participants with multiple myeloma (MM), or in combination with pomalidomide, bortezomib, carfilzomib, or daratumumab in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Groups: Group 1: MM Maintenance Therapy, Group 2: RRMM Doublets, Group 3: RRMM Triplets. The study will enroll approximately 18 participants in Group 1, 66 in Group 2, and 36 in Group 3. Participants will be assigned to one of the following treatment groups as given below: * Group 1 (MM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide * Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide * Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib * Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib * Group 3 RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib * Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide Group 2 Arm 4 is closed for enrollment. The study will be conducted worldwide. The maximum treatment duration in this study for Group 1 is until disease progression or unacceptable toxicity, or up to 2 years for minimal/measurable residual disease (MRD) negative \[-\] participants, whichever occurs first. The maximum treatment duration in this study for Group 2 and Group 3 is until disease progression, unacceptable toxicity or until any other discontinuation criterion is met, whichever occurs first. Overall time to participate in the study is approximately up to 5 years.
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      d1c80111db78692cecac5fdabf26ff238f8df6c6fe7acfa3e81befe14790e5bc

    Preserved source evidence · Not medical advice