Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide.
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NL-OMON25186
- Lead Sponsor
- 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
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 668
Inclusion Criteria
1. Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria ;
2. Age > 65 years or patients <= 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation;
Exclusion Criteria
1. Non-secretory MM;
2. Known hypersensitivity to thalidomide;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Progression free survival, defined as time from registration to progression or death from any cause;<br /> <br>2. Response rate (sCR, CR or VGPR).
- Secondary Outcome Measures
Name Time Method 1. Response rate (sCR, CR, VGPR or PR);<br /><br>2. Overall survival, measured from time of registration;<br /><br>3. Quality of response during maintenance, measured as improvement of response (from start maintenance till progression);<br /><br>4. Time to maximum response, defined as time from registration to maximum response;<br /><br>5. Time to death from relapse/progression (after initial response), measured from time of first relapse/progression;<br /><br>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;<br /><br>7. Quality of life as defined by the EORTC QLQ-C30 definitions.