The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Multiple myeloma
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Koningin Wilhelmina Fonds (KWF)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first);<br>
2. Response rate (CR or PR).
Achtergrond van het onderzoek
Study 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.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Department of Hematology,
P.O. Box 40551
P.W. Wijermans
Leyweg 275
Den Haag 2504 LN
The Netherlands
+31 (0)70 3592556
p.wijermans@hagaziekenhuis.nl
Wetenschappelijk
Department of Hematology,
P.O. Box 40551
P.W. Wijermans
Leyweg 275
Den Haag 2504 LN
The Netherlands
+31 (0)70 3592556
p.wijermans@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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 proteïnuria);
5. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL195 |
| NTR-old | NTR232 |
| Ander register | : Ho49 |
| ISRCTN | ISRCTN90692740 |