Carfilzomib, Cyclophosphamide, Dexamethasone in Multiple Myeloma
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.