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

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-004007-34-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 668

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 658

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 carcinoma
- Not able and/or not willing to use adequate contraception
- Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified