Panobinostat and Carfilzomib in Treating Participants With Relapsed or Refractory Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 58
Summary
- Conditions
- Non-Secretory Plasma Cell Myeloma
- Plasmacytosis
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the maximum recommended dose (MRD) of the combination of carfilzomib and panobinostat in patients with relapsed/refractory multiple myeloma (RRMM). (Phase I) II. To determine the overall response rate (stable disease [SD], minimal response [MR], partial response [...
PRIMARY OBJECTIVES: I. To determine the maximum recommended dose (MRD) of the combination of carfilzomib and panobinostat in patients with relapsed/refractory multiple myeloma (RRMM). (Phase I) II. To determine the overall response rate (stable disease [SD], minimal response [MR], partial response [PR], very good partial response [VGPR], near complete response/complete response [nCR/CR] of the combination. (Phase Ib) SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR), stable disease (SD), minimal response (MR), partial response (PR), very good partial response (VGPR), near complete response/complete response (nCR/CR). (Phase I) II. To determine the time to progression (TTP). (Phase I and Ib) III. To determine the progression free survival (PFS). (Phase I and Ib) IV. To determine the time to best response. (Phase I and Ib) V. To determine time to next therapy. (Phase I and Ib) VI. To determine duration of response. (Phase I and Ib) VII. To determine the overall response rate (SD, MR, PR, VGPR, nCR/CR) of the combination. (Phase Ib) VIII. To assess the safety of the combination. (Phase Ib) OUTLINE: This is a phase I and Ib dose escalation study. Participants receive carfilzomib intravenously (IV) over 30 minutes on days 1, 2, 8, 9, 15, and 16 and panobinostat orally (PO) once daily (QD) on days 1, 3, 5, 8, 10, and 12 of each course. Courses repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, participants may continue carfilzomib IV on days 1, 2, 15, and 16, and panobinostat PO on days 1, 3, 5, 8, 10, and 12 of each course. If the disease becomes worse, participants can receive carfilzomib on the original dosing schedule (days 1, 2, 8, 9, 15, and 16 of each course). After completion of study treatment, participants are followed up at 30 days.
Tracking Information
- NCT #
- NCT01301807
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Robert Orlowski M.D. Anderson Cancer Center
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