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
- Conditions
- Kahlers diseaseMultiple Myeloma10035227
- Registration Number
- NL-OMON50624
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
- Previously untreated patients with a confirmed diagnosis of symptomatic
multiple myeloma according to IMWG criteria, - Age > 65 years or patients *
65 not eligible for high dose chemotherapy and peripheral stem cell
transplantation, - WHO performance status 0-3 for patients <75 years and WHO
performance status 0-2 for patients *75 years , - Measurable disease as defined
by the presence of M-protein in serum or urine or proven plasmocytoma by
biopsy, - Written informed consent
- Non-secretory MM, - Known hypersensitivity to thalidomide, - Systemic AL
amyloidosis , - Polyneuropathy, grade 2 or higher , - Severe cardiac
dysfunction (NYHA classification II-IV) , - Severe pulmonary dysfunction , -
Significant hepatic dysfunction (total bilirubin *30 umol/l or transaminases *3
times normal level), unless related to myeloma , - Creatinine clearance < 30
ml/min, - Patients with active, uncontrolled infections , - Pre-treatment with
cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course
of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are
allowed., - Patients known to be HIV-positive , - History of active malignancy
during the past 5 years, except basal carcinoma of the skin or stage 0 cervical
carcinoma , - Not able and/or not willing to use adequate contraception , -
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Progression free survival, defined as time from registration to progression<br /><br>or death from any cause<br /><br>- Response rate (sCR, CR or VGPR)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Response rate (sCR, CR, VGPR or PR)<br /><br>- Overall survival, measured from time of registration<br /><br>- Quality of response during maintenance, measured as improvement of response<br /><br>(from start maintenance till progression)<br /><br>- Time to maximum response, defined as time from registration to maximum<br /><br>response<br /><br>- Safety and toxicity as defined by type, frequency and severity of adverse<br /><br>events as defined by the National Cancer Institute (NCI) Common Terminology<br /><br>Criteria (CTC), version 3.0<br /><br>- Quality of life.</p><br>