A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone(VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma.
- Conditions
- Multiple Myeloma (Kahler’s disease)
- Registration Number
- NL-OMON28960
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
1. Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS, i.e. at least one of the CRAB criteria should be present;
2. Measurable disease as defined by the presence of M-protein in serum or urine (serum Mprotein > 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light chain ratio;
Exclusion Criteria
1. Known intolerance of Boron;
2. Systemic AL amyloidosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first);<br /><br>2. For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first;<br /><br>3. For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first.
- Secondary Outcome Measures
Name Time Method 1. Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment;<br /><br>2. Overall survival measured from the time of registration /randomization R1/ randomization R2. Patients still alive or lost to follow up are censored at the date they were last known to be alive;<br /><br>3. Toxicity.