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Randomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.


- candidate number1408
- NTR NumberNTR232
- ISRCTNISRCTN90692740
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsHo49 
- Public TitleRandomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.
- Scientific TitleRandomized phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone.
- ACRONYMHOVON 49 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 (Kahler's disease)
- Inclusion criteria1. 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 criteria1. Known intolerance to Thalidomide;
2. Systemic AL amyloidosis;
3. Polyneuropathy;
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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2002
- planned closingdate1-jan-2007
- Target number of participants420
- InterventionsPatients will be randomized on entry between:
Arm A:
8 cycles of Melphalan + Prednisone.
Arm B:
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 outcome1. 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 outcome1. 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).
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. P.W. Wijermans
- CONTACT for SCIENTIFIC QUERIESDr. 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
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase:
phase III.

Study objectives:
evaluation of the effect of Thalidomide added to the standard induction therapy with Melphalan and Prednisone in myeloma patients.

Patient population:
patients with multiple myeloma, previously untreated, Salmon & Durie stage IB, II and III, age > 65 years.

Study design:
prospective, multicenter, randomized.

Duration of treatment:
expected duration of 8 chemotherapy cycles is 8 months.
- Main changes (audit trail)
- RECORD6-sep-2005 - 15-nov-2009


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