Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- University of Maryland, Baltimore
- Study ID
- NCT04896658
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Belantamab Mafodotin, Cyclophosphamide and Dexamethasone — DRUGStudy drug
Study Details
Evaluate the efficacy and safety of Belantamab Mafodotin, cyclophosphamide, and dexamethasone in patients with Relapsed/Refractory Multiple Myeloma
Key Dates
- Start date
- Dec 3, 2021
- Status verified
- Mar 2025
- Primary completion
- Jun 30, 2023
- Completion
- Dec 1, 2024
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A1. 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.
- Experimental: Arm B1. 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.
Primary Outcome Measure
Number of Participants With Adverse Events in Dose Escalation [ Time Frame: Up to 6 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | - |
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