Relapsed or refractory multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10051381
Conditions
Interventions
Trade Name: RIBOMUSTIN
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Bendamustine
CAS Number: 3543-75-7
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-85 years at the time of signing the informed consent form ? Life expectancy of at least 3 months ? Able to adhere to the study visit schedule and other protocol requirements ? Relapsed or refractory MM after autologous SCT or conventional chemotherapy ? No more than 4 prior therapeuric regimens for MM ? Measurable disease (>10g/L monoclonal gammopathy or > 200 mg/day proteinuria) ? All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy. ? Eastern Cooperative Oncology Group (ECOG) performance status of ? 2 at study entry ? Laboratory test results within these ranges: - Absolute neutrophil count ? 1.0 x 109/L - Platelet count ? 75 x 109/L - Creatinine clearance > 30 ml/h) - Total bilirubin ? 1.5 mg/dL - Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ? 2 x ULN or ? 5 x ULN if hepatic lesions are present. ? Disease free of prior malignancies for ? 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast ? Fertile patients must use effective contraception during and for 6 months after study treatment ? Patients must sign on an Informed Consent Form 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: ? Absence of the Informed Consent Form signed by the patient ? Pregnant or breast feeding females ? Serious concomitant systemic disorder which, in the Protocol: BVD-CLEM 01-10 Final Version n?2? 22 July 2010 3 opinion of the investigator, may compromise the safety of the patient or the patient’s ability to complete the study. ? Use of any other experimental drug or therapy within 28 days of baseline. ? Known hypersensitivity to the study drugs ? Received 4 or more prior therapeutic regimens for MM ? Any prior use of bendamustine ? Refractory to bortezomib or remission duration less than 6 months with prior therapy containing bortezomib ? Peripheral neuropathy = grade 2 ? Heart diseases grade III-IV NYHA ? Uncontrolled diabetes or glaucoma ? Prior allogeneic stem cell transplantation ? Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan ? Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the overall response rate after 4 cycles of treatment;Secondary Objective: to assess toxicity, progression-free survival, time to progression, overall survival, CR rate, additional response in responding patients following 2 additional treatment cycles, the time to maximum response;Primary end point(s): Primary objective of the study is to determine the activity of the bendamustine/bortezomib/dexamethasone regimen by assessment of the objective response rate (CR + PR) in the intention-to-treat population. | — |
Countries
Italy
Outcome results
None listed