E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 = 2 at study entry • Laboratory test results within these ranges: - Absolute neutrophil count >or= 1.5 x 109/L - Platelet count >or= 100 x 109/L - Serum creatinine <or= 250 µmol/l - AST (SGOT) and ALT (SGPT) <or= 3 x ULN • Disease free of prior malignancies for >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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 29 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The 28th day of the last cycle of the maintenance phase, for the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |