Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT01208766
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1503
Inclusion Criteria:<br><br> - Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III<br> according to the International Staging System ISS (see appendix A), i.e. at least<br> one of the CRAB criteria should be present;<br><br> - Measurable disease as defined by the presence of M-protein in serum or urine (serum<br> M-protein> 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light<br> chain ratio;<br><br> - Age 18-65 years inclusive;<br><br> - WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by<br> comorbid conditions);<br><br> - Negative pregnancy test at inclusion if applicable;<br><br> - Written informed consent.<br><br>Inclusion for randomisation 1:<br><br> - WHO performance 0-2;<br><br> - Bilirubin and transaminases < 2.5 times the upper limit of normal values;<br><br> - A suitable stem cell graft containing at least 4 x 106 CD34+ cells/kg (or according<br> to national guidelines).<br><br>Inclusion for randomisation 2:<br><br> - Bilirubin and transaminases < 2.5 times the upper limit of normal values;<br><br> - ANC >= 0.5 x 109/l and platelets > 20 x 10^9/l;<br><br> - Patient is able to adhere to the requirements of the Lenalidomide Pregnancy<br> Prevention Risk Management Plan.<br><br>Exclusion Criteria:<br><br> - Known intolerance of Boron;<br><br> - Systemic AL amyloidosis;<br><br> - Primary Plasmacell Leukemia;<br><br> - Non-secretory MM;<br><br> - Previous chemotherapy or radiotherapy except local radiotherapy in case of local<br> myeloma progression or corticosteroids maximum 5 days for symptom control;<br><br> - Severe cardiac dysfunction (NYHA classification II-IV);<br><br> - Significant hepatic dysfunction, unless related to myeloma;<br><br> - Patients with GFR <15 ml/min,<br><br> - Patients known to be HIV-positive;<br><br> - Patients with active, uncontrolled infections;<br><br> - Patients with neuropathy, CTC grade 2 or higher;<br><br> - Patients with a history of active malignancy during the past 5 years with the<br> exception of basal carcinoma of the skin or stage 0 cervical carcinoma;<br><br> - Patients who are not willing or capable to use adequate contraception during the<br> therapy (all men, all pre-menopausal women);<br><br> - Lactating women.<br><br>Exclusion for randomisation 1:<br><br> - Severe pulmonary, neurologic, or psychiatric disease;<br><br> - CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;<br><br> - Allogeneic Stem Cell Transplantation (Allo SCT) planned;<br><br> - Progressive disease.'<br><br>Exclusion for randomisation 2:<br><br> - Progressive disease;<br><br> - Neuropathy, except CTCAE grade 1;<br><br> - CTCAE grade 3-4 polyneuropathy during Bortezomib treatment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).;For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first;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 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.;Toxicity;Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment.