Multiple Myeloma
Conditions
Interventions
Arm A: 9 cycles of MP-Thal, followed by thalidomide maintenance.
Arm B: 9 cycles of MP-Len, followed by lenalidomide maintenance.
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center; Erasmus MC; Postbus 2040; 3000 CA Rotterdam Tel: +31 10 704 1560; Fax +31 10 704 1028 e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria ; 2. Age > 65 years or patients = 75 years; 4. Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy; 5. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Non-secretory MM; 2. Known hypersensitivity to thalidomide; 3. Systemic AL amyloidosis; 4. Polyneuropathy, grade 2 or higher; 5. Severe cardiac dysfunction (NYHA classification II-IV); 6. Severe pulmonary dysfunction; 7. Significant hepatic dysfunction (total bilirubin >= 30 ¦Ìmol/l or transaminases >= 3 times normal level), unless related to Myeloma; 8. Creatinine clearance <30 ml/min; 9. Patients with active, uncontrolled infections; 10. Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors; 11. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed; 12. 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; 13. Not able and/or not willing to use adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression free survival, defined as time from registration to progression or death from any cause; 2. Response rate (sCR, CR or VGPR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate (sCR, CR, VGPR or PR); 2. Overall survival, measured from time of registration; 3. Quality of response during maintenance, measured as improvement of response (from start maintenance till progression); 4. Time to maximum response, defined as time from registration to maximum response; 5. Time to death from relapse/progression (after initial response), measured from time of first relapse/progression; 6. 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; 7. Quality of life as defined by the EORTC QLQ-C30 definitions. | — |
Contacts
Public ContactS. Zweegman
VUMC Afd. Hematologie; Postbus 7057; 1007 MB Amsterdam
Outcome results
None listed