NCT05590377 · REGISTRY CONDITION SEARCH

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or 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: 2026-01-30

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)

→

outcome · POSTED

Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity

→

outcome · POSTED

Phase 2a: Overall Response Rate (ORR)

→

outcome · NOT POSTED

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa

→

outcome · NOT POSTED

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa

→

outcome · NOT POSTED

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

→

outcome · NOT POSTED

Phase 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration

→

outcome · NOT POSTED

Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa

→

outcome · NOT POSTED

Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa

→

outcome · NOT POSTED

Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa

→

outcome · NOT POSTED

Phase 1: Volume of Distribution at Steady State After Intravenous (IV) Administration for Modakafusp Alfa

→

outcome · NOT POSTED

Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab

→

outcome · NOT POSTED

Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab

→

outcome · NOT POSTED

Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab

→

outcome · NOT POSTED

Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Daratumumab

→

outcome · NOT POSTED

Phase 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Daratumumab

→

outcome · POSTED

Phase 1: Overall Response Rate (ORR)

→

outcome · NOT POSTED

Phase 1 and Phase 2a: Duration of Response (DOR)

→

outcome · NOT POSTED

Phase 1 and Phase 2a: Progression Free Survival (PFS)

→

outcome · NOT POSTED

Phase 1 and Phase 2a: Overall Survival (OS)

→

outcome · POSTED

Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)

→

outcome · NOT POSTED

Phase 1 and Phase 2a: Titer of Anti-drug Antibodies

→

outcome · NOT POSTED

Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug

→

outcome · POSTED

Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)

→

outcome · POSTED

Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

→

outcome · POSTED

Phase 2a: Clinical Benefit Rate (CBR)

→

outcome · POSTED

Phase 2a: Duration of Clinical Benefit (DCB)

→

outcome · POSTED

Phase 2a: Disease Control Rate (DCR)

→

outcome · POSTED

Phase 2a: Duration of Disease Control

→

outcome · POSTED

Phase 2a: Time to Progression (TTP)

→

outcome · POSTED

Phase 2a: Time to Response (TTR)

→

outcome · POSTED

Phase 2a: Time to Next Treatment (TTNT)

→

outcome · POSTED

Phase 2a: Number of Participants Reporting One or More TEAEs and Per Severity

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: 1. Documented multiple myeloma (MM) diagnosis per IMWG criteria. 2. Measurable disease, defined as at least 1 of the following: 1. Serum M protein ≥0.5 grams per deciliter \[g/dL\] (≥5 g/L) on serum protein electrophoresis (SPEP). 2. Urine M protein ≥200 mg/24 hours on urine protein electrophoresis (UPEP). 3. Serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal. 3. For participants in the Phase 1 Dose Escalation only: Must have received at least 3 prior lines of therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-CD38 monoclonal antibody (mAb) drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy. 4. For participants in Phase 2a Dose Finding only: 1. Received 1 to 3 prior line(s) of antimyeloma therapy. 2. Must be refractory to prior lenalidomide treatment. 3. Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment. 4. Documented progressive disease on or after the last regimen. 5. Participants must have PR or better to at least 1 line of prior therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening. Exclusion Criteria: 1. Prior exposure to modakafusp alfa. 2. Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma. 3. Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade ≤1 or baseline, except for alopecia. 4. Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing. 5. Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV). 6. Participant has congestive heart failure (New York Heart Association Grade ≥II), cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension. 7. Participant has QT interval corrected by the Fridericia method \>480 milliseconds \[msec\] (Grade ≥2). 8. Participant has a chronic condition that will require the chronic use of systemic corticosteroids \>10 milligrams per day (mg/d) of prednisone or equivalent on top of any required corticosteroids for multiple myeloma (MM).
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Modakafusp alfa 80 mg, infusion, intravenously (IV), once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
intervention Names
Drug: Modakafusp Alfa
Drug: Daratumumab
label
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
type
EXPERIMENTAL
description
Modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
intervention Names
Drug: Modakafusp Alfa
Drug: Daratumumab
label
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
type
EXPERIMENTAL
description
Modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
intervention Names
Drug: Modakafusp Alfa
Drug: Daratumumab
label
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
type
EXPERIMENTAL
description
Modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
intervention Names
Drug: Modakafusp Alfa
Drug: Daratumumab
label
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
type
EXPERIMENTAL
description
Modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
intervention Names
Drug: Modakafusp Alfa
Drug: Daratumumab
label
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
type
EXPERIMENTAL

interventions

arm Group Labels
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
description
Modakafusp alfa intravenous infusion
name
Modakafusp Alfa
other Names
TAK-573
type
DRUG
arm Group Labels
Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
description
Daratumumab SC injection
name
Daratumumab
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

description
DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0.
measure
Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)
time Frame
Phase 1: Cycle 1 (cycle length=28 days)
description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0.
measure
Phase 1: Number of Participants Reporting One or More TEAEs and Per Severity
time Frame
Phase 1: Up to 15.9 months
description
ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria.
measure
Phase 2a: Overall Response Rate (ORR)
time Frame
Phase 2a: Up to 15.9 months

secondary Outcomes

measure
Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Volume of Distribution at Steady State After Intravenous (IV) Administration for Modakafusp Alfa
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
measure
Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Daratumumab
time Frame
Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)

Full study description

brief Summary: The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.
detailed Description: The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy in combination with daratumumab in participants with relapsed or refractory multiple myeloma (RRMM). The study will consist of 2 phases: Phase 1 Dose Escalation and a Phase 2a Dose Finding. The study will enroll approximately 58 patients. Approximately 18 participants will be enrolled in the Phase 1 Dose Escalation/De-escalation and two dose levels of modakafusp alfa in combination with daratumumab SC will be selected to be further explored in the randomized Phase 2a Dose Finding part of the study wherein, approximately 40 participants will be randomly assigned by chance (like flipping a coin) to one of the two treatment groups: * Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab * Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 60 months. Participants who discontinue study drug treatment for reasons other than progressive disease will continue progression-free survival (PFS) follow-up every 4 weeks from the end of treatment (EOT) visit until the occurrence of progressive disease, death, the start of subsequent systemic antineoplastic therapy, study termination, whichever occurs first.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-627c371d7068fa78e667
requested nct id
NCT05590377
primary nct id
NCT05590377
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
6c654bb22108dd79f13fdcee22ba80d6cd8ae4f74653815555dcc2274b39b837
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-627c371d7068fa78e667
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT05590377
occurrences
context exact
NCT05590377
end
11
exact text
NCT05590377
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/34/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
447968fc0d75c98f05133912148064cfab705599eca5538d0647e8fa4d70ca9e
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice