Weekly carfilzomib plus cyclophosphamide and dexamethasone in the treatment of relapsed/refractory multiple myeloma: Final results from the MCRN‐003/MYX.1 single arm phase II trial

The MCRN‐003/CCTGMYX.1 is a single arm phase II trial of weekly carfilzomib, cyclophosphamide and dexamethasone (wKCd), exploring a convenient immunomodulator (IMiD)‐free regimen in relapsed myeloma. Weekly carfilzomib (20/70 mg/m2), dexamethasone 40 mg and cyclophosphamide 300 mg/m2 was delivered o...

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Bibliographic Details
Published in:American journal of hematology 2021-05, Vol.96 (5), p.552-560
Main Authors: Venner, Christopher P., LeBlanc, Richard, Sandhu, Irwindeep, White, Darrell, Belch, Andrew R., Reece, Donna E., Chen, Christine, Dolan, Sean, Lalancette, Marc, Louzada, Martha, Kew, Andrea, McCurdy, Arleigh, Monteith, Bethany, Reiman, Tony, McDonald, Gail, Sherry, Max, Gul, Engin, Chen, Bingshu E., Hay, Annette E.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cardiovascular Diseases - chemically induced
Cyclophosphamide
Cyclophosphamide - administration & dosage
Cyclophosphamide - adverse effects
Cytogenetics
Dexamethasone
Dexamethasone - administration & dosage
Dexamethasone - adverse effects
Drug Administration Schedule
Dyspnea - chemically induced
Female
Hematologic Diseases - chemically induced
Hematology
Humans
Immunomodulation
Infections - etiology
Kaplan-Meier Estimate
Male
Middle Aged
Multiple myeloma
Multiple Myeloma - drug therapy
Multiple Myeloma - genetics
Myeloma Proteins - analysis
Oligopeptides - administration & dosage
Oligopeptides - adverse effects
Patient Selection
Prognosis
Progression-Free Survival
Proteasome inhibitors
Recurrence
Salvage Therapy
Steroids
Targeted cancer therapy
Toxicity
Treatment Outcome
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Summary:The MCRN‐003/CCTGMYX.1 is a single arm phase II trial of weekly carfilzomib, cyclophosphamide and dexamethasone (wKCd), exploring a convenient immunomodulator (IMiD)‐free regimen in relapsed myeloma. Weekly carfilzomib (20/70 mg/m2), dexamethasone 40 mg and cyclophosphamide 300 mg/m2 was delivered over 28‐day cycles. The primary endpoint was overall response after four cycles. Secondary endpoints included toxicity, response depth, PFS and OS. Exploratory endpoints included the impact of cytogenetics, prior therapy exposure and serum free light chain (sFLC) escape; 76 patients were accrued. The ORR was 85% (68% ≥very good partial response [VGPR] and 29% ≥complete response [CR]). The median OS and PFS were 27 and 17 months respectively. High‐risk cytogenetics conferred a worse ORR (75% vs. 97%, p = .013) and median OS (18 months vs. NR, p = .002) with a trend toward a worse median PFS (14 vs. 22 months, p = .06). Prior proteasome inhibitor (PI) or lenalidomide did not influence OS or PFS. The sFLC was noted in 15% of patients with a median PFS of 17 months when included as a progression event. The most common ≥ grade 3 non‐hematologic adverse events were infectious (40%), vascular (17%) and cardiac (15%). The wKCD is a safe and effective regimen in relapse, especially for patients ineligible for lenalidomide‐based therapies.
ISSN:0361-8609
1096-8652
DOI:10.1002/ajh.26147