Experimental myeloma combo trial halted early
NCT ID NCT05556616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new drug called modakafusp alfa (TAK-573) combined with standard myeloma treatments in 15 adults with multiple myeloma. The main goal was to check safety and find the best dose. The study was terminated early, so we have limited information on how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- modakafusp alfa (also called TAK-573) given with lenalidomide, bortezomib, carfilzomib, daratumumab, or pomalidomide
- What this could lead to
- If successful, this could point toward a new combination treatment option for multiple myeloma that may help control the disease.
- What could go wrong
- This was a very early (phase 1) trial with only 15 participants, and it was terminated early, so results are limited. The drug may cause side effects or not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Delta
Roeselare, Roeselare West-Vlaanderen, 8800, Belgium
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CHU UCL Namur site Godinne
Yvoir, Namur, 5530, Belgium
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Cancer Center At Greater Baltimore Medical Center
Baltimore, Maryland, 21153, United States
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Clinica Universidad de Navarra, Dept of Oncology
Pamplona, 31008, Spain
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Clinica Universidad de Navarra-Sede Madrid
Madrid, 28027, Spain
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Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119, United States
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Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
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Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
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Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
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NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
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New York University School of Medicine
New York, New York, 10016, United States
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Novant Health Cancer Institute
Charlotte, North Carolina, 28204, United States
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Novant Health Cancer Institute - Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
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Rambam Health Care Campus (RHCC) - Meyer Children's Hospital - Pediatric Diabetes & Obesity Clinic
Haifa, 31999, Israel
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Scripps Health
San Diego, California, 92121, United States
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The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
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Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas