drugset / Trial / NCT04302324
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
Phase 2
Active not recruiting
11 enrolled
Weill Medical College of Cornell University
Janssen Scientific Affairs, LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, non-randomized, phase 2 study in which patients will receive daratumumab (subcutaneous, SC) in combination with clarithromycin/pomalidomide/dexamethasone (D-ClaPd) until progressive disease (PD) or unacceptable toxicity. This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of clarithromycin/pomalidomide/dexamethasone with daratumumab SC (D-ClaPd) will yield higher Very Good Partial Response (VGPR) rates in relapsed/refractory multiple myeloma patients than historical pomalidomide/dexamethasone treatment.
Timeline
- Start
- 2021-10-28
- Primary completion
- 2024-05-31
- Completion
- 2027-12-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 500 mg | Oral |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Intravenous |