|- candidate number||1408|
|- NTR Number||NTR232|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||Ho49 |
|- Public Title||Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.|
|- Scientific Title||Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.|
|- ACRONYM||HOVON 49 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 (Kahler's disease)|
|- Inclusion criteria||1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria;|
2. Age > 65 years;
3. WHO performance status 0-3;
4. Measurable tumorparameter (M-protein or Bence Jones prote´nuria);
5. Written informed consent.
|- Exclusion criteria||1. Known intolerance to Thalidomide;|
2. Systemic AL amyloidosis;
4. Severe cardiac dysfunction (NYHA classification II-IV);
5. Severe pulmonary dysfunction;
6. Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
7. Renal failure with dependency on dialysis;
8. Patients with active, uncontrolled infections;
9. Pre-treatment with cytostatic drug or alpha interferon;
10. Patients known to be HIV-positive;
11. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2002|
|- planned closingdate||1-jan-2007|
|- Target number of participants||420|
|- Interventions||Patients will be randomized on entry between:|
8 cycles of Melphalan + Prednisone.
8 cycles of Melphalan + Prednisone + Thalidomide.
Non responders will be taken off protocol treatment after 3 cycles of therapy. If after 8 cycles a plateau-phase is reached therapy can be stopped. If after 8 cycles a patient still shows improvement of the disease, therapy will be continued until a plateau phase has been reached.
Thalidomide (50 mg/day) in arm B will be continued until disease progression.
|- Primary outcome||1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first);|
2. Response rate (CR or PR).
|- Secondary outcome||1. Quality of life;|
2. Toxicity of the combination therapy;
3. Overall survival measured from time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive;
4. Progression free survival measured from the time of achievement of PR (or CR) to date of relapse, progression or death from any cause (whichever occurs first).
|- Trial web site||http://www.hovon.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.W. Wijermans|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.W. Wijermans|
|- Sponsor/Initiator ||VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Erasmus Medical Center, Daniel den Hoed Cancer Center |
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
|- Brief summary||Study phase: |
evaluation of the effect of Thalidomide added to the standard induction therapy with Melphalan and Prednisone in myeloma patients.
patients with multiple myeloma, previously untreated, Salmon & Durie stage IB, II and III, age > 65 years.
prospective, multicenter, randomized.
Duration of treatment:
expected duration of 8 chemotherapy cycles is 8 months.
|- Main changes (audit trail)|
|- RECORD||6-sep-2005 - 15-nov-2009|