This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a biochemical progression, without CRAB, during Rd treatment.
This protocol is a phase II multicenter, open label study designed to determine whether the addiction of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU). The pre-treatment period includes: screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above. Subjects who meet all the inclusion criteria will be enrolled. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed progression disease (PD), all patients are to be followed for survival every 1-3 months via telephone or office visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.
Policlinico Umberto I
Rome, Italy
Efficacy in terms of response and survival
To assess the efficacy (response rate according to International Myeloma Working Group (IMWG) definition, appendix 2) after the addiction of Cyclophosphamide to Revlimid-Dexamethasone (CRd) in Multiple Myeloma patients, who experienced a biochemical progression during Rd treatment, without myeloma-related organ damage, CRAB.
Time frame: 2 years
Safety in terms of hematological and non-hematological adverse events
The following evaluations will be conducted to assess the safety: * Adverse events * Concomitant medication and supportive therapies * Electrocardiogram and Chest Radiograph. * Medical history, physical examination, neurotoxicity assessment * Vital signs, body weight, height, and body surface area * Clinical laboratory evaluations (hematology, chemistry) * Health outcomes assessment
Time frame: 2 years
The progression free survival (PFS)
Time frame: 2 years
The overall survival (OS)
Time frame: 2 years
Duration of time to progression (TTP)
Time frame: 2 years
Time to next therapy (TNT)
Time frame: 2 years
Identification of patient's subgroups according to specific prognostic factors
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.