Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1/2 Completed 25 enrolled University of Chicago Multiple Myeloma Research Foundation · collab National Cancer Institute (NCI) · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Timeline

Start: 2012-08-13
Primary completion: 2025-11-14
Completion: 2025-11-14

Outcome

Met primary endpoint

paper The ORR after 4 cycles of KPd at the MTD was 27/34 (79%; 95% confidence interval [CI], 62%-91%), meeting the statistical threshold for efficacy. PMID 36763537 ↗

paper The rate of nCR or better after 4 cycles was 11/28 (39%; 95% CI, 22%-59%), meeting the statistical threshold for efficacy. PMID 36763537 ↗

Publications

Derman BA, Zonder J, Reece D, Cole C, Berdeja J, Stefka AT, Major A, Kin A, Griffith K, Jasielec J, Jakubowiak AJ. Phase 1/2 study of carfilzomib, pomalidomide, and dexamethasone with and without daratumumab in relapsed multiple myeloma. Blood Adv. 2023 Oct 10;7(19):5703-5712. doi: 10.1182/bloodadvances.2022008866.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carfilzomib	Other / unclassified	27 mg/m2	Intravenous
Subject	Daratumumab	Monoclonal antibody	—	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Pomalidomide	Other / unclassified	4 mg	Oral