A Phase 2 interventional study of Carfilzomib and Dexamethasone in Multiple Myeloma, sponsored by PETHEMA Foundation. Status unknown at 24 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by PETHEMA Foundation · Phase 2, Interventional, and Treatment
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:
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.
Treatment will consist of 28-days cycles with:
Arm 1 (experimental arm):
Arm 2 (control arm):
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.
Treatments will be administered until progressive disease (PD) or unacceptable toxicity. Carfilzomib and cyclophosphamide will be provided by the sponsor. Dexamethasone may be utilized per a site's standard practice and will not be provided by the sponsor.
Patients must have measurable disease, defined as follows:
Exclusion Criteria:
Biochemical and haematological abnormalities as specified below:
Other relevant diseases or adverse clinical conditions:
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
Drug: Carfilzomib · Drug: Dexamethasone · Drug: cyclophosphamide
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 , in 28 days cycles
Drug: Carfilzomib · Drug: Dexamethasone
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 oral at a dose of 20 mg (10 mg for patients \>75 years) days 1, 2, 8, 9, 15 and 16
cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
Progression free survival (PFS)
PFS is defined as the number of months from randomization to the disease progression or death due to any cause, whichever occurs first. The disease outcome determined will be the primary data source for the final PFS analysis.
Time frame: 36 months
Safety of carfilzomib, dexamethasone and cyclophosphamide in number of participants with treatment-related adverse events as assessed by CTCAE v4.0
the safety as determined by the incidence of clinical and laboratory toxicities
Time frame: 2 years
Efficacy of carfilzomib, dexamethasone and cyclophosphamide in number and rate of responses obtained
Evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in terms of rate of response in multiple myeloma (MM) patients.
Time frame: 2 years
Time-to progression (TTP)
Duration from randomization to disease progression, with deaths due to causes other than progression censored.
Time frame: 36 months
Overall Survival (OS)
Duration from the date of randomization until the date of death. The patients lost to follow-up will be censored at the date of the last visit.
Time frame: 36 months
Efficacy of carfilzomib, dexamethasone and cyclophosphamide in rate of achievement of immunophenotypic CR
Evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in terms of achievement of immunophenotypic CR in multiple myeloma (MM) patients.
Time frame: 2 years
Plan to share: Undecided
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PETHEMA Foundation