Trials / Recruiting
RecruitingNCT05789303
Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma
Phase II Study of Belantamab Mafodotin in Combination With Carfilzomib, Pomalidomide, and Dexamethasone (KPd) in Patients With Relapsed Multiple Myeloma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
Detailed description
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment. The purpose of this research is to gather information on the safety and effectiveness of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone for patients with a history of two or more prior lines of myeloma therapy. This combination is not FDA-approved, although carfilzomib and pomalidomide, are separately FDA-approved agents in combination with dexamethasone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belantamab mafodotin | Cycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles) |
| DRUG | Carfilzomib | Cycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15 Cycles 2-8: 56 mg/m2 on Days 1/8/15 Cycles 9+: 56 mg/m2 on Days 1/15 |
| DRUG | Pomalidomide | 3 mg Day 1-21 of 28-day Cycle |
| DRUG | Dexamethasone | Cycles 1-4: 40 mg Days 1/8/15/22 Cycles 5+: 20 mg Days 1/8/15/22 |
Timeline
- Start date
- 2023-05-30
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
- First posted
- 2023-03-29
- Last updated
- 2025-12-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05789303. Inclusion in this directory is not an endorsement.