Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Abdullah Khan
- Study ID
- NCT04956302
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bortezomib — DRUGGiven SC
- Daratumumab and Hyaluronidase-fihj — DRUGGiven SC
- Dexamethasone — DRUGGiven PO or IV
- Panobinostat Lactate — DRUGGiven PO
Study Details
This phase I trial studies the possible benefits and side effects of adding panobinostat to a combination of daratumumab, bortezomib and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory). Panobinostat may stop or slow multiple myeloma by blocking the growth of new blood vessels necessary for cancer growth. Giving panobinostat in combination with daratumumab, bortezomib and dexamethasone may work better in treating relapsed/refractory multiple myeloma.
Key Dates
- Start date
- Sep 27, 2021
- Status verified
- Jun 2024
- Primary completion
- Jun 16, 2022
- Completion
- Jun 16, 2022
Study Design
- Enrollment
- 1 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (panobinostat, daratumumab, bortezomib, dexa)Patients receive panobinostat PO QD on days 1, 3, 5, 15, 17, 19, daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, bortezomib SC on days 1, 8, 15, 22 and dexamethasone PO (IV on days of daratumumab and hyaluronidase-fihj administration) QD on days 1, 8, 15, 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Recommended phase 2 dose [ Time Frame: End of cycle 1 (1 cycle = 28 days) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | - |
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