|- candidate number||5148|
|- NTR Number||NTR1630|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2009|
|- Secondary IDs||2007-004007-34 EudraCT nummer|
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||HOVON 87 MM|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Multiple myeloma|
|- Inclusion criteria||1. Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria ;|
2. Age > 65 years or patients ¡Ü 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 ¡Ý 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 ¡Ý 30 ¦Ìmol/l or transaminases ¡Ý 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-feb-2009|
|- planned closingdate|
|- Target number of participants||452|
|- Interventions||Arm A: 9 cycles of MP-Thal, followed by thalidomide maintenance.|
Arm B: 9 cycles of MP-Len, followed by lenalidomide maintenance.
|- 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.
|- Timepoints||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.
|- Trial web site||www.hovon.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Mw. Dr. S. Zweegman|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Dr. S. Zweegman|
|- Sponsor/Initiator ||HOVON Data Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Study phase: |
Randomized phase III
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.
Previously untreated symptomatic patients with MM. Age >65 or £ 65 and patient ineligible for high dose therapy and peripheral stem cell transplantation.
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)|
|- RECORD||13-jan-2009 - 19-aug-2013|