New drug combo aims to deepen remission in myeloma transplant patients
NCT ID NCT04680468
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether adding the targeted drug belantamab mafodotin before and after a stem cell transplant can help people with multiple myeloma achieve deeper remission. About 41 participants will receive the drug alongside standard treatments. The main goal is to see how many become free of minimal residual disease (MRD) one year after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belantamab mafodotin (an antibody-drug conjugate)
- What this could lead to
- If successful, this could offer a new way to achieve deeper remission in multiple myeloma patients undergoing stem cell transplant, potentially delaying relapse.
- What could go wrong
- This is a small, early-phase study (41 people) without a control group, so results may not apply broadly. The drug can cause eye problems and other side effects, and it is not yet proven to improve long-term outcomes.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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41 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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. Must be able to understand the study procedures and have signed written, informed consent. 2. Must be 18 years of age or older at enrollment. 3. Must have started therapy for active multiple myeloma within 12 months of enrollment. 4. Must have an ECOG performance status of 0-2. 5. Have received no more than 2 prior lines of induction therapy (induction regimen not specified by protocol), with no prior progressive disease by International Myeloma Working Group (IMWG) criteria. 6. Must be in at least a partial response (PR) but not in a complete response (CR) or better after at least 4 cycles of induction therapy, per IMWG consensus criteria. 7. Eligible by institutional criteria to receive melphalan at a dose of 200 mg/m2. 8. Eligible to receive lenalidomide maintenance therapy post-ASCT. 9. Adequate bone marrow and organ function at enrollment. 10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1. Is not a woman of childbearing potential (WOCBP), OR 2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. 11. Male participants are eligible to participate if they agree to the following during belantamab mafodotin treatment and for 6 months after the last dose of belantamab mafodotin to allow for clearance of any altered sperm: 1. Refrain from donating sperm PLUS either: 2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR Must agree to use contraception/barrier as detailed in the protocol. 12. All prior treatment-related toxicities must be grade 1 or less at the time of enrollment except for alopecia. Exclusion Criteria: 1. Must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. 2. Must not have received treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug 3. Must not be simultaneously enrolled in any interventional clinical trial 4. Must not have amyloidosis or POEMS syndrome. 5. Must not be pregnant or lactating. 6. Must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, severe hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria. 7. Must not have any evidence of active mucosal or internal bleeding 8. History of an active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill other criteria. 9. Participant must not have evidence of cardiovascular risk, as defined in the protocol. 10. Must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures. 11. Must not have invasive malignancies other than disease under study, unless the second malignancy has been definitively treated or has been medically stable for at least 2 years and, in the opinion of the principal investigator, will not affect the evaluation of the effects of clinical trial treatment. 12. Must not have an active infection requiring antibiotic treatment. 13. Any major surgery within the last 4 weeks prior to enrollment. 14. Must not have current corneal epithelial disease except mild changes in corneal epithelium 15. Must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment 16. Must not have evidence for active hepatitis B infection (i.e. positive hepatitis B surface antigen or nucleic acid-based testing) at screening or within 3 months prior to first dose of belantamab mafodotin. 17. Must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. 18. Must not have evidence of active HIV infection.
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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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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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