Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.
Completed
- Conditions
- Multiple myeloma
- Registration Number
- NL-OMON25578
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 420
Inclusion Criteria
1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria;
2. Age > 65 years;
Exclusion Criteria
1. Known intolerance to Thalidomide;
2. Systemic AL amyloidosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first);<br /><br>2. Response rate (CR or PR).
- Secondary Outcome Measures
Name Time Method 1. Quality of life;<br /><br>2. Toxicity of the combination therapy;<br /><br>3. Overall survival measured from time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive;<br /><br>4. Progression free survival measured from the time of achievement of PR (or CR) to date of relapse, progression or death from any cause (whichever occurs first).