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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.


- candidate number5148
- NTR NumberNTR1630
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2009
- Secondary IDs2007-004007-34 EudraCT nummer
- Public TitleRandomized 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.
- Scientific TitleRandomized 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.
- ACRONYMHOVON 87 MM
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma
- Inclusion criteria1. 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 criteria1. 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 mol/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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-feb-2009
- planned closingdate
- Target number of participants452
- InterventionsArm A: 9 cycles of MP-Thal, followed by thalidomide maintenance.
Arm B: 9 cycles of MP-Len, followed by lenalidomide maintenance.
- Primary outcome1. Progression free survival, defined as time from registration to progression or death from any cause;
2. Response rate (sCR, CR or VGPR).
- Secondary outcome1. 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.
- Timepoints1. 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.
- Trial web sitewww.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMw. Dr. S. Zweegman
- CONTACT for SCIENTIFIC QUERIESMw. Dr. S. Zweegman
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
HOVON
- PublicationsN/A
- Brief summaryStudy 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.
- Main changes (audit trail)Participant: 668 instead of 452 (9-8-2013)
- RECORD13-jan-2009 - 19-aug-2013


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