A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
NCT01464034 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2022-08-01
Summary
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy.
Conditions
Interventions
- DRUG
-
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
- DRUG
-
PO daily on Days 1-21, every 28 Days
- DRUG
-
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Celgene Corporation
collaborator INDUSTRY -
Criterium, Inc.
lead INDUSTRY
Principal Investigators
-
Jatin Shah, MD · AMyC
-
Brian GM Durie, MD · AMyC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2020-07-31
- Completion
- 2020-07-31
Countries
- United States
Study Locations
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