drugset / Trial / NCT03336073

Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

Phase 2 Unknown 199 enrolled PETHEMA Foundation

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open label, phase II randomized controlled study that will evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in R/R MM patients. For this purpose, R/R MM patients that have received 1-3 prior lines of therapy, and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive: * Experimental arm: carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, dexamethasone by mouth (po) at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16 and cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15, in 28 days cycles; or * Control arm: the same treatment but without cyclophosphamide. Once the first 12 cycles are administered, treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms. Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mg/m2 (20 mg/m2 only in the first infusion) during the cycles 1 and 2. If tolerability is acceptable, the dose could be increased up to 70 mg/m2 since the cycle 3. Treatment will be continued until progression, unacceptable toxicity or investigator or patient decision.

Timeline

Start: 2017-12-18
Primary completion: 2024-12
Completion: 2024-12

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carfilzomib	Other / unclassified	56 mg/m2	Intravenous
Subject	Carfilzomib	Other / unclassified	70 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	10 mg	Oral
Subject	Dexamethasone	Small molecule	20 mg	Oral

Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications