Relapsed / Refractory Multiple MyelomaPhase 2REBELNCT07748689
Comparing Lower Versus Standard Doses of Belantamab Mafodotin With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma.
A Phase 2 study testing Belantamab Mafodotin, Pomalidomide and Dexamethasone in people with Relapsed / Refractory Multiple Myeloma, run by Polish Myeloma Consortium.
Trial summary
This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed / Refractory Multiple Myeloma
- What is being tested?
- Belantamab Mafodotin, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Male or female, 18 years or older (at the time consent is obtained).
- Have a confirmed diagnosis of MM as defined by the IMWG criteria.
- Eastern Cooperative Oncology Group performance status of 0-2.
- 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.
- Must have at least ONE aspect of measurable disease, defined as one the following:
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- Urine M-protein excretion ≥200 mg/24 h, or
- Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or
- 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.
- 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:
- AutoSCT was >100 days prior to the first dose of study medication
- No active bacterial, viral, or fungal infection(s) present
- 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.
- Compliance with contraceptive precautions in accordance with the protocol.
- 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)
Who cannot join
- Active plasma cell leukemia, amyloidosis, POEMS syndrome, allogeneic SCT or currently active GvHD.
- 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.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Prior treatment with pomalidomide and belantamab mafodotin in any treatment line.
- 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.
- Any major surgery within the last 4 weeks.
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- Any other active malignancy, except the disease is medically stable for at least 2 years or not require active therapy other than hormonal.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin, drugs chemically related, or any of the components of the study treatment.
- Evidence of active mucosal or internal bleeding.
- 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.
- Intolerance or contraindications to anti-viral prophylaxis.
- Active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.
- Known HIV infection, unless the participant can meet all of the following criteria:
- Established ART for at least 4 weeks and HIV viral load < 400 copies/mL within Screening Period.
- CD4+ T-cell (CD4+) counts ≥350 cells/μL.
- 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.
- 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:
- RNA test negative.
- 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.
- Participants with hepatitis B will be excluded unless the patient is:
- HBcAb+, HBsAg- with undetectable HBV DNA at screening.
- 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.
- 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.
- Ongoing Grade 3 or higher peripheral neuropathy or neuropathic pain
- Active or history of venous thromboembolism within the past 3 months.
- Contraindications to anti-thrombotic prophylaxis.
- Current corneal disease except for mild punctate keratopathy.
- 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.
- Pregnant or lactating female.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy With Reduced Versus Standard Dose of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (REBEL)
This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma.
Participants will be randomly assigned to receive either a reduced dose or a standard dose of belantamab mafodotin in combination with pomalidomide and dexamethasone. The study will evaluate treatment response, side effects, and minimal residual disease (MRD), which is a measure of the number of myeloma cells that remain after treatment. The goal is to determine whether treatment can be optimized while maintaining disease control and reducing treatment-related toxicity.
Read the detailed description
Multiple myeloma remains an incurable plasma cell malignancy despite substantial advances in treatment. Although currently available therapies have improved patient outcomes, most patients eventually experience disease relapse and require additional treatment options. Therefore, there remains a need to optimize therapeutic strategies that can provide durable disease control while minimizing treatment-related toxicity.
Belantamab mafodotin is a B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate that has demonstrated clinically meaningful anti-myeloma activity in patients with relapsed or refractory multiple myeloma. Combination treatment with belantamab mafodotin, pomalidomide, and dexamethasone represents a promising therapeutic approach for this patient population. However, treatment-related adverse events, particularly ocular toxicities, may require dose modifications or treatment interruptions and can affect the overall treatment experience.
The REBEL study has been designed to investigate whether a reduced-dose strategy of belantamab mafodotin can maintain clinical benefit while improving tolerability. The study will also evaluate the use of minimal residual disease (MRD) assessment as part of a treatment-guidance approach. MRD has emerged as an important measure of treatment response and may provide additional information about the depth and durability of disease control in multiple myeloma.
By evaluating treatment effectiveness, safety, and MRD outcomes, this study aims to generate evidence that may support a more individualized approach to belantamab mafodotin-based therapy in patients with relapsed or refractory multiple myeloma. The results may help define treatment strategies that optimize the balance between disease control and treatment burden.
- Conditions
- Relapsed / Refractory Multiple Myeloma
- Being tested
- Belantamab Mafodotin, Pomalidomide, Dexamethasone
- Keywords
- multiple myeloma, Relapsed/Refractory Multiple Myeloma, Belantamab Mafodotin, MRD-Guided Therapy, Measurable Residual Disease
- Medical subject headings
- Multiple Myeloma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab MafodotinDrug
Belantamab mafodotin is administered intravenously in combination with pomalidomide and dexamethasone. The study evaluates a reduced-dose strategy versus a standard-dose strategy of belantamab mafodotin in patients with relapsed or refractory multiple myeloma.
PomalidomideDrug
Pomalidomide is administered orally in combination with belantamab mafodotin and dexamethasone. Participants receive pomalidomide according to the protocol-defined treatment regimen
DexamethasoneDrug
Dexamethasone is administered orally in combination with belantamab mafodotin and pomalidomide. Participants receive dexamethasone according to the protocol-defined treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone | Experimental | Participants receive a reduced-dose regimen of belantamab mafodotin administered intravenously in combination with pomalidomide and dexamethasone. Belantamab mafodotin is administered at 2.5 mg/kg in Cycle 1 and 1.9 mg/kg thereafter according to the protocol-defined schedule. Pomalidomide is administered orally on Days 1-21 of each 28-day cycle, and dexamethasone is administered orally once weekly. Participants may continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation. Receives: Drug: Belantamab Mafodotin; Drug: Pomalidomide; Drug: Dexamethasone |
| Arm B - Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone | Active comparator | Participants receive a standard-dose regimen of belantamab mafodotin administered intravenously in combination with pomalidomide and dexamethasone. Belantamab mafodotin is administered at 2.5 mg/kg in Cycle 1 and 1.9 mg/kg every 4 weeks thereafter according to the protocol-defined schedule. Pomalidomide is administered orally on Days 1-21 of each 28-day cycle, and dexamethasone is administered orally once weekly. Participants may continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation. Receives: Drug: Belantamab Mafodotin; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response Rate (ORR), defined as the proportion of participants achieving at least a partial response according to International Myeloma Working Group (IMWG) response criteria.
Measured: From randomization up to approximately 6 years
Incidence of Grade 2 or Higher Ocular Toxicity
Incidence of ocular toxicity of at least Grade 2 severity, assessed using the keratopathy and visual acuity (KVA) scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: From randomization up to approximately 6 years
Secondary outcomes (12)
Incidence and Severity of Adverse Events
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), Grade 3 or higher adverse events, and Grade 3 or higher laboratory toxicities, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Measured: From first study treatment dose up to approximately 6 years
Undetectable Measurable Residual Disease (uMRD) Rate
Percentage of participants with measurable residual disease (MRD) less than 10^-5 in bone marrow among participants in complete response at 6, 12, 18, 24, 30, 36, and 42 months from randomization.
Measured: At 6, 12, 18, 24, 30, 36, and 42 months from randomization
Sustained Undetectable Measurable Residual Disease (uMRD) Negativity Rate
Percentage of participants with sustained undetectable measurable residual disease (uMRD) negativity, defined as two consecutive MRD-negative results in participants with complete response separated by at least 12 months.
Measured: From randomization up to approximately 6 years
Overall Response Rate (ORR)
Percentage of participants achieving an overall response, including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to International Myeloma Working Group (IMWG) criteria.
Measured: From randomization up to approximately 6 years
Complete Response (CR) Rate
Percentage of participants achieving at least a complete response (CR) according to International Myeloma Working Group (IMWG) criteria.
Measured: From randomization up to approximately 6 years
Very Good Partial Response (VGPR) Rate
Percentage of participants achieving at least a very good partial response (VGPR) according to International Myeloma Working Group (IMWG) criteria.
Measured: From randomization up to approximately 6 years
Duration of Response (DoR)
Duration of response (DoR), defined as the time from first documented response to disease progression or death, whichever occurs first.
Measured: From first documented response up to approximately 6 years
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Measured: From randomization up to approximately 6 years
Overall Survival (OS)
Overall survival (OS), defined as the time from randomization to death from any cause.
Measured: From randomization up to approximately 6 years
Duration of CR-MRD-Negative Disease (DoR-MRD)
Duration of CR-MRD-negative disease (DoR-MRD), defined as the time from achievement of complete response with MRD negativity to disease progression or death, whichever occurs first.
Measured: From first documented CR-MRD-negative disease up to approximately 6 years
Change From Baseline in EORTC QLQ-C30 Score
Change from baseline in quality of life as assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Measured: From randomization up to approximately 6 years
Change From Baseline in EORTC QLQ-MY20 Score
Change from baseline in quality of life as assessed using the European Organisation for Research and Treatment of Cancer Myeloma Module Quality of Life Questionnaire (EORTC QLQ-MY20).
Measured: From randomization up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2033 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed / Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Myeloma Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland, GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748689
- Sponsor's protocol ID
- PMC012
- Other IDs
- 2025-525096-83-00, 2025
- Acronym
- REBEL
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy With Reduced Versus Standard Dose of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (REBEL)
- ClinicalTrials.gov ID
- NCT07748689
- Acronym / sponsor ID
- REBEL / PMC012
- Conditions
- Relapsed / Refractory Multiple Myeloma
- Keywords
- multiple myeloma, Relapsed/Refractory Multiple Myeloma, Belantamab Mafodotin, MRD-Guided Therapy, Measurable Residual Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Polish Myeloma ConsortiumUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland, GlaxoSmithKline
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2033 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma.
Participants will be randomly assigned to receive either a reduced dose or a standard dose of belantamab mafodotin in combination with pomalidomide and dexamethasone. The study will evaluate treatment response, side effects, and minimal residual disease (MRD), which is a measure of the number of myeloma cells that remain after treatment. The goal is to determine whether treatment can be optimized while maintaining disease control and reducing treatment-related toxicity.
Detailed description
Multiple myeloma remains an incurable plasma cell malignancy despite substantial advances in treatment. Although currently available therapies have improved patient outcomes, most patients eventually experience disease relapse and require additional treatment options. Therefore, there remains a need to optimize therapeutic strategies that can provide durable disease control while minimizing treatment-related toxicity.
Belantamab mafodotin is a B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate that has demonstrated clinically meaningful anti-myeloma activity in patients with relapsed or refractory multiple myeloma. Combination treatment with belantamab mafodotin, pomalidomide, and dexamethasone represents a promising therapeutic approach for this patient population. However, treatment-related adverse events, particularly ocular toxicities, may require dose modifications or treatment interruptions and can affect the overall treatment experience.
The REBEL study has been designed to investigate whether a reduced-dose strategy of belantamab mafodotin can maintain clinical benefit while improving tolerability. The study will also evaluate the use of minimal residual disease (MRD) assessment as part of a treatment-guidance approach. MRD has emerged as an important measure of treatment response and may provide additional information about the depth and durability of disease control in multiple myeloma.
By evaluating treatment effectiveness, safety, and MRD outcomes, this study aims to generate evidence that may support a more individualized approach to belantamab mafodotin-based therapy in patients with relapsed or refractory multiple myeloma. The results may help define treatment strategies that optimize the balance between disease control and treatment burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone | Experimental | Drug: Belantamab Mafodotin, Drug: Pomalidomide, Drug: DexamethasoneParticipants receive a reduced-dose regimen of belantamab mafodotin administered intravenously in combination with pomalidomide and dexamethasone. Belantamab mafodotin is administered at 2.5 mg/kg in Cycle 1 and 1.9 mg/kg thereafter according to the protocol-defined schedule. Pomalidomide is administered orally on Days 1-21 of each 28-day cycle, and dexamethasone is administered orally once weekly. Participants may continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation. |
| Arm B - Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone | Active comparator | Drug: Belantamab Mafodotin, Drug: Pomalidomide, Drug: DexamethasoneParticipants receive a standard-dose regimen of belantamab mafodotin administered intravenously in combination with pomalidomide and dexamethasone. Belantamab mafodotin is administered at 2.5 mg/kg in Cycle 1 and 1.9 mg/kg every 4 weeks thereafter according to the protocol-defined schedule. Pomalidomide is administered orally on Days 1-21 of each 28-day cycle, and dexamethasone is administered orally once weekly. Participants may continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined reason for discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- Male or female, 18 years or older (at the time consent is obtained).
- Have a confirmed diagnosis of MM as defined by the IMWG criteria.
- Eastern Cooperative Oncology Group performance status of 0-2.
- 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.
Key exclusion criteria (29 listed)
- Active plasma cell leukemia, amyloidosis, POEMS syndrome, allogeneic SCT or currently active GvHD.
- 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.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Prior treatment with pomalidomide and belantamab mafodotin in any treatment line.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab MafodotinBelantamab mafodotin is administered intravenously in combination with pomalidomide and dexamethasone. The study evaluates a reduced-dose strategy versus a standard-dose strategy of belantamab mafodotin in patients with relapsed or refractory multiple myeloma. | Drug | Arm A - Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone, Arm B - Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone |
| PomalidomidePomalidomide is administered orally in combination with belantamab mafodotin and dexamethasone. Participants receive pomalidomide according to the protocol-defined treatment regimen | Drug | Arm A - Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone, Arm B - Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone |
| DexamethasoneDexamethasone is administered orally in combination with belantamab mafodotin and pomalidomide. Participants receive dexamethasone according to the protocol-defined treatment regimen | Drug | Arm A - Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone, Arm B - Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone |
Primary outcome
Overall Response Rate (ORR)
Time frame: From randomization up to approximately 6 years
Overall Response Rate (ORR), defined as the proportion of participants achieving at least a partial response according to International Myeloma Working Group (IMWG) response criteria.
Incidence of Grade 2 or Higher Ocular Toxicity
Time frame: From randomization up to approximately 6 years
Incidence of ocular toxicity of at least Grade 2 severity, assessed using the keratopathy and visual acuity (KVA) scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
12 secondary outcomes
Incidence and Severity of Adverse Events
Time frame: From first study treatment dose up to approximately 6 years
Undetectable Measurable Residual Disease (uMRD) Rate
Time frame: At 6, 12, 18, 24, 30, 36, and 42 months from randomization
Sustained Undetectable Measurable Residual Disease (uMRD) Negativity Rate
Time frame: From randomization up to approximately 6 years
Overall Response Rate (ORR)
Time frame: From randomization up to approximately 6 years
Complete Response (CR) Rate
Time frame: From randomization up to approximately 6 years
Very Good Partial Response (VGPR) Rate
Time frame: From randomization up to approximately 6 years
Duration of Response (DoR)
Time frame: From first documented response up to approximately 6 years
Progression-Free Survival (PFS)
Time frame: From randomization up to approximately 6 years
Overall Survival (OS)
Time frame: From randomization up to approximately 6 years
Duration of CR-MRD-Negative Disease (DoR-MRD)
Time frame: From first documented CR-MRD-negative disease up to approximately 6 years
Change From Baseline in EORTC QLQ-C30 Score
Time frame: From randomization up to approximately 6 years
Change From Baseline in EORTC QLQ-MY20 Score
Time frame: From randomization up to approximately 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belantamab Mafodotin, Pomalidomide and Dexamethasone in people with Relapsed / Refractory Multiple Myeloma, run by Polish Myeloma Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof Jamroziak, Professor (+48 22 599 29 41, krzysztof.jamroziak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From randomization up to approximately 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.