NL-OMON50624
Completed
Phase 3
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 - HOVON 87 MM/NMSG 18
HOVO0 sites500 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Kahlers disease
- Sponsor
- HOVO
- Enrollment
- 500
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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