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Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma

Belantamab Mafodotin, Cyclophosphamide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

NCT04896658•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+20 more criteria

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.

Locations (1)

University of Maryland

Baltimore, Maryland, United States

Key Dates

Start Date

December 3, 2021

Primary Completion Date

June 30, 2023

Completion Date

December 1, 2024

Last Updated

April 3, 2025

Enrollment

ACTUAL participants

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

Belantamab Mafodotin, Cyclophosphamide and Dexamethasone

DRUG

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

NCT04973605

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

NCT05862012

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients