Can a lower dose of a myeloma drug keep the disease in check with fewer side effects?
NCT ID NCT07748689
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial asks whether a reduced dose of belantamab mafodotin, combined with pomalidomide and dexamethasone, can control relapsed or refractory multiple myeloma as effectively as the standard dose while causing fewer side effects. Adults with this blood cancer who have had at least one prior therapy are randomly assigned to receive either the reduced or standard dose. The study tracks treatment response, minimal residual disease (a sensitive measure of remaining cancer cells), and side effects, especially eye-related toxicity.
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 (reduced vs standard dose) in combination with pomalidomide and dexamethasone
- What this could lead to
- If a lower dose works as well as the standard, it could offer a gentler treatment option for relapsed/refractory multiple myeloma, reducing eye-related side effects while maintaining disease control.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The reduced dose might be less effective, and the combination still carries risks like eye toxicity and other side effects.
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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About 228 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2033
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. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the REBEL study protocol. 2. Male or female, 18 years or older (at the time consent is obtained). 3. Have a confirmed diagnosis of MM as defined by the IMWG criteria. 4. Eastern Cooperative Oncology Group performance status of 0-2. 5. Have been previously treated with at least 1 prior line of MM therapy, including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles), and must have documented disease progression during or after their most recent therapy. 6. Must have at least ONE aspect of measurable disease, defined as one the following: 1. Urine M-protein excretion ≥200 mg/24 h, or 2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or 3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\<0.26 or \>1.65) only if the patient has no measurable urine or serum M spike. 7. Have undergone autologous stem cell transplant (autoSCT) or are considered transplant ineligible. Participants with a history of autoSCT are eligible for study participation provided the following eligibility criteria are met: 1. AutoSCT was \>100 days prior to the first dose of study medication 2. No active bacterial, viral, or fungal infection(s) present 8. All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events v5.0) must be Grade ≤1 at the time of enrolment, except for alopecia and Grade ≤ 2 peripheral neuropathy. 9. Compliance with contraceptive precautions in accordance with the protocol. 10. Organ System Function - adequate organ system functions as defined by the laboratory assessments * Hematologic: * Absolute neutrophil count - ≥1.5× 10 9/L (Without growth factor support for the past 14 days, excluding erythropoietin) * Hemoglobin - ≥8.0 g/dL * Platelets - ≥75 × 10 9/L * Hepatic: * Total bilirubin - ≤1.5 × ULN; (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%) * Alanine aminotransferase (ALT) - ≤2.5 × ULN * Renal o eGFR ≥30 mL/min/1.73 m2 (as calculated by MDRD formula) Exclusion Criteria: 1. Active plasma cell leukemia, amyloidosis, POEMS syndrome, allogeneic SCT or currently active GvHD. 2. Anti-MM therapy or use of an investigational drug within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; Prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs. 3. Plasmapheresis within 7 days prior to the first dose of study drug. 4. Prior treatment with pomalidomide and belantamab mafodotin in any treatment line. 5. Evidence of cardiovascular risk including: current clinically significant (CS) untreated arrhythmias (eg. CS ECG abnormalities, 2nd degree (Mobitz Type II) or 3rd degree AV block); history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; heart failure NYHA III or IV class; uncontrolled hypertension. 6. Any major surgery within the last 4 weeks. 7. Any other active malignancy, except the disease is medically stable for at least 2 years or not require active therapy other than hormonal. 8. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin, drugs chemically related, or any of the components of the study treatment. 9. Evidence of active mucosal or internal bleeding. 10. Cirrhosis or current unstable liver or biliary disease assessed by Investigator. Stable non-cirrhotic chronic liver disease is acceptable if other entry criteria are met. 11. Intolerance or contraindications to anti-viral prophylaxis. 12. Active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment. 13. Known HIV infection, unless the participant can meet all of the following criteria: 1. Established ART for at least 4 weeks and HIV viral load \< 400 copies/mL within Screening Period. 2. CD4+ T-cell (CD4+) counts ≥350 cells/μL. 3. No history of AIDS-defining opportunistic infections within the last 12 months. NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant. 14. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before the first dose of the study intervention, unless the participant can meet the following criteria: 1. RNA test negative. 2. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks. 15. Participants with hepatitis B will be excluded unless the patient is: 1. HBcAb+, HBsAg- with undetectable HBV DNA at screening. 2. HBsAg+ at screening or within 3 months before first study dose, but has undetectable HBV DNA, and a highly effective antiviral treatment started at least 4 weeks prior to first dose of study intervention. 16. Presence of active serious renal conditions (e.g., requiring dialysis or any other condition that could affect the participant's safety). Isolated proteinuria due to MM is acceptable if other criteria are fulfilled. 17. Ongoing Grade 3 or higher peripheral neuropathy or neuropathic pain 18. Active or history of venous thromboembolism within the past 3 months. 19. Contraindications to anti-thrombotic prophylaxis. 20. Current corneal disease except for mild punctate keratopathy. 21. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (also lab abnormalities) that could interfere with participant's safety, obtaining ICF or compliance to the study procedures. 22. Pregnant or lactating female.
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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.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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