Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code:
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria - Age > 65 years or patients = 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation - WHO performance status 0-3 for patients =65 years) yes F.1.3.1 Number of subjects for this age range 658
Exclusion criteria
Exclusion criteria: - Non-secretory MM - Known hypersensitivity to thalidomide - Systemic AL amyloidosis - Polyneuropathy, grade 2 or higher - Severe cardiac dysfunction (NYHA classification II-IV) - Severe pulmonary dysfunction - Significant hepatic dysfunction (total bilirubin =30 umol/l or transaminases =3 times normal level), unless related to myeloma - Creatinine clearance < 30 ml/min - Patients with active, uncontrolled infections - Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed. - Patients known to be HIV-positive - History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma - Not able and/or not willing to use adequate contraception - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare progression free survival with Melphalan/Prednisone (MP)-Thalidomide followed by thalidomide maintenance versus MP-Lenalidomide followed by maintenance with lenalidomide ; Secondary Objective: - To compare (stringent) complete and very good partial response with MP-Thalidomide versus MP-Lenalidomide - To compare overall survival with MP-Thalidomide versus MP-Lenalidomide - To assess and compare overall response* with MP-Thalidomide versus MP-Lenalidomide - To assess time to maximum response with MP-Thalidomide versus MP-Lenalidomide - To assess the effect of maintenance therapy with thalidomide alone following MP-Thalidomide induction or lenalidomide following MP-Lenalidomide, in terms of improvement of response - To assess and compare the time from relapse/progression (after initial response) to death in patients having been treated with MP-Thalidomide versus MP-Lenalidomide - To assess the impact on the quality of life of thalidomide compared with lenalidomide - To assess the safety and toxicity of induction of both regimens * overall response will be defined as (stringent) complete response, very good partial response and partial response ; Primary end point(s): - Progression free survival, defined as time from registration to progression or death from any cause - Response rate (sCR, CR or VGPR) ;Timepoint(s) of evaluation of this end point: After cycle 1; 3; 5 ; 7; 9 & every three months during maintenance and every 6 months during Follow-Up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - After cycle 1; 3; 5 ; 7; 9 & every three months during maintenance and every 6 months during Follow-Up. - Quality of life: at baseline; after cycle 3; 9; after 6 and 12 months maintenance & off treatment. ; Secondary end point(s): •Overall response rate defined as sCR, CR, VGPR or PR •Overall survival, measured from time of registration •Quality of response during maintenance, measured as improvement of response (from start maintenance till progression) •Time to maximum response, defined as time from registration to maximum response •Time to death from relapse/progression (after initial response), measured from time of first relapse/progression •Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC), version 3.0 •Quality of life as defined by the EORTC QLQ-C30 definitions. | — |
Countries
Belgium, Denmark, Netherlands, Norway, Sweden
Contacts
Public ContactHOVON Data Center
Erasmus MC
Outcome results
None listed