No registrations found.
ID
Source
Brief title
Health condition
Multiple Myeloma
Sponsors and support
In addition HOVON is supported by the Dutch Cancer Society.
Intervention
Outcome measures
Primary outcome
1. Progression free survival, defined as time from registration to progression or death from any cause;
2. Response rate (sCR, CR or VGPR).
Secondary outcome
1. Response rate (sCR, CR, VGPR or PR);
2. Overall survival, measured from time of registration;
3. Quality of response during maintenance, measured as improvement of response (from start maintenance till progression);
4. Time to maximum response, defined as time from registration to maximum response;
5. Time to death from relapse/progression (after initial response), measured from time of first relapse/progression;
6. Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC), version 3.0;
7. Quality of life as defined by the EORTC QLQ-C30 definitions.
Background summary
Study phase:
Randomized phase III
Study objective:
To compare progression free survival with MP+Thalidomide (MP-Thal) followed by maintenance with thalidomide versus MP+Lenalidomide (MP-Len) followed by maintenance with lenalidomide.
To compare (stringent) complete and very good partial response with MP-Thal versus MP-Len.
To compare overall survival with MP-Thal versus MP-Len.
To assess and compare overall response and time-to-response with MP-Thal versus MP-Len.
To assess the effect of maintenance therapy with thalidomide alone following MP-Thal induction or lenalidomide alone following MP-Len induction.
To assess and compare the time from relapse/progression (after initial response) to death in patients having been treated with MP-Thal versus MP-Len.
To asses the quality of life with these regimens.
To assess the safety and toxicity of both regimens.
Patient population:
Previously untreated symptomatic patients with MM. Age >65 or <= 65 and patient ineligible for high dose therapy and peripheral stem cell transplantation.
Study design:
Prospective, multicenter, randomized
Duration of treatment:
Expected duration of induction treatment: 9 months. Maintenance therapy with lenalidomide or thalidomide will be given until relapse/progression. All patients will be followed until 10 years after registration.
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
1. At entry;
2. Before start of treatment;
3. During induction therapy;
4. After 1, 3, 5 ,7 and 9 cycles;
5. During maintenance therapy every 2 months.
Intervention
Arm A: 9 cycles of MP-Thal, followed by thalidomide maintenance.
Arm B: 9 cycles of MP-Len, followed by lenalidomide maintenance.
S. Zweegman
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4442604
s.zweegman@vumc.nl
S. Zweegman
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4442604
s.zweegman@vumc.nl
Inclusion criteria
1. Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria ;
2. Age > 65 years or patients <= 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation;
3. WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients >= 75 years;
4. Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy;
5. Written informed consent.
Exclusion criteria
1. Non-secretory MM;
2. Known hypersensitivity to thalidomide;
3. Systemic AL amyloidosis;
4. Polyneuropathy, grade 2 or higher;
5. Severe cardiac dysfunction (NYHA classification II-IV);
6. Severe pulmonary dysfunction;
7. Significant hepatic dysfunction (total bilirubin >= 30 ¦Ìmol/l or transaminases >= 3 times normal level), unless related to Myeloma;
8. Creatinine clearance <30 ml/min;
9. Patients with active, uncontrolled infections;
10. Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors;
11. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed;
12. 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;
13. Not able and/or not willing to use adequate contraception.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1552 |
| NTR-old | NTR1630 |
| Other | EudraCT nummer : 2007-004007-34 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |