A randomized phase III study on the effect of Bortezomib combined with Adriamycin, Dexamethasone (AD) for induction treatment, followed by High Dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma.
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NL-OMON29206
- 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
- 800
Inclusion Criteria
1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
2. Age 18-65 years inclusive;
Exclusion Criteria
1. Known intolerance of Thalidomide or Boron;
2. Systemic AL amyloidosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (i.e. time from registration to progression or death from any cause whichever occurs first).
- Secondary Outcome Measures
Name Time Method 1. Response (PR, VGPR and CR);<br /><br>2. Overall survival measured from the 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>3. Toxicity;<br /><br>4. Progression free survival from HDM (i.e. time from last HDM treatment to progression or death from any cause whichever occurs first for patients who received at least PR on HDM);<br /><br>5. Progression free survival analysed as primary endpoint, but patients with an allogeneic transplant not censored. This primarily to check whether censoring has a major impact.