Patient with Multiple Myeloma (MM) in 1st relapse or refractory to 1st line therapy, having received 1st line therapy with conventional chemotherapy without stem cell transplantation (patients 65 years or older or younger than 65 years and ineligible for high-dose therapy plus stem cell transplantation). MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: RIBOMUSTIN
Product Name: Bendamustine
Product Code: B
Pharmaceutical Form: Powder for injection*
Trade Name: VELCADE
Product Name: VELCADE
Product Code: V
Pharmaceutical Form: Powder and
Sponsors
Intergroupe Francophone du Myélome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse) • Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation. • Measurable disease (>10g/L monoclonal gammapathy or > 200 mg/24h proteinuria) • Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by M-component increase of =25% from baseline, in serum and/or urine (the absolute increase in serum must be = 5 g/l - the absolute increase of BJ proteins in urine must be =200 mg/24 h). • Life expectancy of at least 3 months • ECOG performance status or= 1.5 x 109/L - Platelet count >or= 100 x 109/L - Serum creatinine or= 5 years, with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast • Able to adhere to the study visit schedule and other protocol requirements • Using effective contraceptive methods during and for 6 months after study treatment (for fertile men, women of childbearing potential). • Provision of informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. • Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study. • Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy • Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin) • Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan • Use of any other experimental drug or therapy within 28 days prior to the start of study treatment. • Known hypersensitivity to the study drugs • Positive HIV serology or infectious hepatitis type A, B or C. • Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhytmias) • Previous major surgery less than 30 days before start of treatment • Active infection, • Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to determine the efficacy of the bendamustine/bortezomib/dexamethasone regimen by assessment of the overall response rate (CR + PR) after four 28-day consecutives cycles in the intention-to-treat population.;Secondary Objective: Secondary endpoints are the assessment of : • Progression-free survival • Time to progression • Overall survival • Time to maximum response • Rate of additional response in responding patients following 2 consolidation cycles and following 6 maintenance cycles;Primary end point(s): Primary objective: to assess of the overall response rate (CR + PR) after four 28-day consecutives cycles in the intention-to-treat population. Secondary objectives: to assess the progression-free survival, time to progression, overall survival, additional response following 2 consolidation cycles and following 6 maintenance cycles, the time to maximum response and toxicity. | — |
Countries
France
Outcome results
None listed