Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma
Part of paid clinical trials in La Jolla, California.
- Sponsor
- University of California, San Diego
- Study ID
- NCT03590652
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ixazomib — DRUG4mg PO days 1,8,15 on 28-day cycle
- Pomalidomide — DRUG4mg days PO 1-21/28 days
- Dexamethasone — DRUG40mg\*\* PO weekly \*\* starting dose for age \>75 may be 20mg
- Daratumumab-Hyaluronidase-Fihj@1,800 Mg-30,000 Unit/15 mL@SUBCUT@VIAL (ML) — DRUG1800mg SQ weekly x 8 weeks, biweekly x 8 doses, then monthly
Study Details
The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.
Key Dates
- Start date
- Oct 17, 2018
- Status verified
- Oct 2025
- Primary completion
- Jul 2, 2025
- Completion
- Jul 2, 2025
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ixazomib, daratumumab, pomalidomide and dexamethasoneDaratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.
Primary Outcome Measure
Overall Response Rate [ Time Frame: 2 years ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093 | - |
| University of California, Los Angeles | Los Angeles | California | 90024 | - |
| University of California, Davis | Sacramento | California | 95817 | - |
| University of California, San Francisco | San Francisco | California | 94115 | - |
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