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

HOVON Foundation0 sites668 target enrollmentSeptember 14, 2009

Overview

No summary available.

Registry

who.int

Start Date

September 14, 2009

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

HOVON Foundation

•\- 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 plasmacytoma 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

•\- 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.