Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT ID: NCT04896658
Last Updated: 2025-04-03
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-12-03
Study Completion Date
2024-12-01
Brief Summary
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Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma
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Detailed Description
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This is a Phase I/II, open-label study to evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone.
In Phase I, the subjects will be assigned into two arms and there are two dose levels for Belantamab Mafodotin and there are two dose levels of cyclophosphamide in each arm.
In Phase II, once tolerability of the highest planned dose is established, the patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
Belantamab mafodotin was approved by the U.S. Food and Drug Administration (FDA) on Aug 5, 2020, for treating patients with relapsed/refractory multiple myeloma. Cyclophosphamide and dexamethasone are both approved by the FDA. But the combinations with these three drugs to treat people with relapsed/refractory multiple myeloma has not been approved by the FDA.
In Phase I, the subjects will be assigned into two arms and there are two dose levels for Belantamab Mafodotin and there are two dose levels of cyclophosphamide in each arm.
In Phase II, once tolerability of the highest planned dose is established, the patients will be assessed for response rate. The arm with acceptable toxicity and best response will be further assessed in the expansion cohort.
Belantamab mafodotin was approved by the U.S. Food and Drug Administration (FDA) on Aug 5, 2020, for treating patients with relapsed/refractory multiple myeloma. Cyclophosphamide and dexamethasone are both approved by the FDA. But the combinations with these three drugs to treat people with relapsed/refractory multiple myeloma has not been approved by the FDA.
Conditions
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Relapsed/Refractory Multiple Myeloma
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SEQUENTIAL
Phase I
1. Arm A (cycles repeated every 3 weeks)
1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Arm B (cycles repeated every 6 weeks)
1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Phase II : Phase II was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate.
1. Arm A (cycles repeated every 3 weeks)
1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Arm B (cycles repeated every 6 weeks)
1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
Phase II : Phase II was stopped with the FDA withdrawal of the drug approval and reluctance of patients to participate.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm A
1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles.
2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles.
Group Type
EXPERIMENTAL
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone
Intervention Type
DRUG
Study drug
Arm B
1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles.
2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles.
Group Type
EXPERIMENTAL
Belantamab Mafodotin, Cyclophosphamide and Dexamethasone
Intervention Type
DRUG
Study drug
Interventions
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Belantamab Mafodotin, Cyclophosphamide and Dexamethasone
Study drug
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Histologically confirmed diagnosis of Refractory MM; failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody (e.g., daratumumab) alone or in combination, and is refractory to an IMiD (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). (Refractory myeloma is defined as disease that is nonresponsive while on primary or salvage therapy or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve at least minimal response or development of progressive disease (PD) while on therapy).
2. Has measurable disease with at least one of the following:
1. Serum M-protein ≥0.5 g/dL (≥ 5 g/L)
2. Urine M-protein ≥ 200 mg/24h
3. Serum FLC assay: Involved FLC level ≥10 mg/dL and an abnormal ratio (\<0.26 or \>1.65)
3. Provide signed written informed consent.
4. 18 years or older (at the time consent is obtained).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Participants with a history of autologous stem cell transplant or Prior BCMA targeted therapy (e.g. CAR-T cells, BiTes) can enroll on the study provided that:
1. Therapy was \>100 days prior to study enrolment.
2. No active infection(s).
8. Female and Male patients: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
9. Prior treatment-related toxicities must be ≤ Grade 1 except peripheral neuropathy (Grade-2).
9. Any serious and/or unstable pre-existing medical, psychiatric disorder or lab abnormalities that affect patients' safety, obtaining informed consent or compliance with study procedures.
10. Current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
11. Other malignancies except for malignancy from which the patients have been disease-free \> 2 years.
12. Evidence of cardiovascular disease including any of the following:
1. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block.
2. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.
3. Class III or IV heart failure as defined by the New York Heart Association functional classification system.
4. Uncontrolled hypertension.
13. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, daratumumab, bortezomib, boron or mannitol or any other components of the study treatment.
14. Active infection requiring treatment.
15. Known HIV infection.
16. Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb), at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
17. 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.
NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
18. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.
19. Pregnant or lactating female.
20. Concomitant administration of strong P-glycoprotein inhibitors and inhibitors of OATP will be avoided.
2. Has measurable disease with at least one of the following:
1. Serum M-protein ≥0.5 g/dL (≥ 5 g/L)
2. Urine M-protein ≥ 200 mg/24h
3. Serum FLC assay: Involved FLC level ≥10 mg/dL and an abnormal ratio (\<0.26 or \>1.65)
3. Provide signed written informed consent.
4. 18 years or older (at the time consent is obtained).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Participants with a history of autologous stem cell transplant or Prior BCMA targeted therapy (e.g. CAR-T cells, BiTes) can enroll on the study provided that:
1. Therapy was \>100 days prior to study enrolment.
2. No active infection(s).
8. Female and Male patients: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
9. Prior treatment-related toxicities must be ≤ Grade 1 except peripheral neuropathy (Grade-2).
9. Any serious and/or unstable pre-existing medical, psychiatric disorder or lab abnormalities that affect patients' safety, obtaining informed consent or compliance with study procedures.
10. Current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.
11. Other malignancies except for malignancy from which the patients have been disease-free \> 2 years.
12. Evidence of cardiovascular disease including any of the following:
1. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block.
2. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.
3. Class III or IV heart failure as defined by the New York Heart Association functional classification system.
4. Uncontrolled hypertension.
13. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, daratumumab, bortezomib, boron or mannitol or any other components of the study treatment.
14. Active infection requiring treatment.
15. Known HIV infection.
16. Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb), at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
17. 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.
NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
18. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or active plasma cell leukemia at the time of screening.
19. Pregnant or lactating female.
20. Concomitant administration of strong P-glycoprotein inhibitors and inhibitors of OATP will be avoided.
Exclusion Criteria
1. Systemic anti-myeloma therapy within ≤14 days or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to treatment.
2. Systemic treatment with high dose steroids (equivalent to ≥ 60 mg prednisone daily for ≥4 days) within the past 14 days.
3. Symptomatic amyloidosis, active CNS disease, active plasma cell leukemia at the time of screening.
4. Prior allogeneic stem cell transplant (SCT). NOTE - Participants who have undergone syngeneic transplant may be allowed if no history of GvHD.
5. Current corneal epithelial disease except mild punctate keratopathy.
6. Evidence of active bleeding.
7. Any major surgery within the last four weeks.
2. Systemic treatment with high dose steroids (equivalent to ≥ 60 mg prednisone daily for ≥4 days) within the past 14 days.
3. Symptomatic amyloidosis, active CNS disease, active plasma cell leukemia at the time of screening.
4. Prior allogeneic stem cell transplant (SCT). NOTE - Participants who have undergone syngeneic transplant may be allowed if no history of GvHD.
5. Current corneal epithelial disease except mild punctate keratopathy.
6. Evidence of active bleeding.
7. Any major surgery within the last four weeks.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Maryland, Baltimore
OTHER
Sponsor Role
lead
Responsible Party
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Ashraf Badros
Director of Multiple Myeloma Service
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ashraf Badros, MB; ChB
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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University of Maryland
Baltimore, Maryland, United States
Site Status
Countries
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United States
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Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2060GCCC
Identifier Type: -
Identifier Source: org_study_id
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Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
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ACTIVE_NOT_RECRUITING
PHASE3
Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM)
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ACTIVE_NOT_RECRUITING
PHASE2
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
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COMPLETED
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT01734928
COMPLETED
PHASE3
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
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NOT_YET_RECRUITING
PHASE2
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
NCT04126200
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment
NCT05556798
ACTIVE_NOT_RECRUITING
PHASE1
Dinaciclib, Bortezomib, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
NCT01711528
COMPLETED
PHASE1