The hypothesis to be tested is that the outcome in arm II (and Allo BMT) is better than in arm I.
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Remission rate.
Achtergrond van het onderzoek
Study phase: phase III;
Study objective:
evaluation of the effect of myeloablative chemo-/radiotherapy and autologous stem cell transplantation in comparison with chemotherapy alone with respect to the mentioned endpoints. Assessment of the value of risk factors at diagnosis with dose intensity of treatment.
Patient population:
patients with multiple myeloma, stage 2-3, age < 66 years inclusive.
Study design:
prospective, multicenter, randomized;
Duration of treatment:
expected duration of treatment until start of maintenance is approximately 8 months.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm II (and Allo BMT) is better than in arm I.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will be treated with 3x VAD (vincristine, doxorubicine, dexamethasone). Patients <=55 yrs with a HLA identical sibling will proceed to Allo BMTAll other eligible patients will be randomized between:
Arm I:
PBSC pheresis after cyclophosphamide priming (cyclophosphamide, mesnum, G-CSF), IDM (melphalan, G-CSF) q 8 weeks 2 courses. In case of PR/CR maintenance therapy with IFN-alpha-2a until relapse. PBSCT may be performed after reinduction or relapse.
Arm II:
PBSC pheresis after cyclophosphamide priming (cyclophosphamide, mesnum, G-CSF), IDM (melphalan, G-CSF) q 8 weeks 2 courses. In case of PR/CR intensive treatment with cyclophosphamide/TBI and autologous transplantation, maintenance with IFN-alpha-2a until relapse.
Publiek
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Wetenschappelijk
Department of Hematology (B02.226),
P.O. Box 85500
H.M. Lokhorst
Utrecht 3508 GA
The Netherlands
+31 (0)88 7557230
h.lokhorst@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
At entry:
1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie;
2. Age < 66 years;
3. WHO performance status 0-3;
4. Informed consent;
For IFN maintenance and PBSCT or ABMT:
5. At least PR after induction therapy;
6. WHO performance status 0-2;
7. Suitable peripheral stem or bone marrow graft;
8. No active infections;
9. Absence of severe cardiac, pulmonary, neurologic, psychiatric disease;
10. Serum creatinine, bilirubin and transaminases of less than 2.5x upper limit of normal values;
11. Platelet count > 50x10^9/l;
12. Absolute neutrophil count > 1x10^9/l;
13. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
At entry:
1. Received more than 2 courses of melphalan, prednisone or VMCP;
2. Severe cardiac disease (= severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45% with presence of normal hemoglobin), severe pulmonary, neurologic or metabolic disease- Inadequate liver function, i.e. bilirubin >=2.5x upper normal value;
3. Prior malignancies except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma;
4. Prior extensive radiotherapy involving the myelum (precluding total body irradiation).
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 | NL283 |
| NTR-old | NTR321 |
| Ander register | : Ho24 |
| ISRCTN | ISRCTN82155239 |
Samenvatting resultaten
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2. H.M. Lokhorst, C.M. Segeren, L.F. Verdonck, B. van der Holt, R. Raymakers, M.H.J. van Oers, R.M.Y. Barge, H.C. Schouten, P.H.M. Westveer, M.M.C. Steijaert, J.J. Cornelissen and P. Sonneveld. Partially T-cell-depleted allogeneic stem-cell transplantation for first-line treatment of multiple myeloma: a prospective evaluation of patients treated in the phase III study HOVON 24 MM. Journal of Clinical Oncology, 21(9), 1728-1733. 2003;
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3. C.M. Segeren, P. Sonneveld, B. van der Holt, E. Vellenga, A.J. Croockewit, G.E.G. Verhoef, J.J. Cornelissen, M.R. Schaafsma, M.H.J. van Oers, P.W. Wijermans, W.E. Fibbe, S. Wittebol, H.C. Schouten, M. van Marwijk Kooy, D.H. Biesma, J.W. Baars, R. Slater, M.M.C. Steijaert, I. Buijt and H.M. Lokhorst. Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study. Blood, 101, 2144-2151. 2003;
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4. C.M. Segeren. P. Sonneveld, B. van der Holt, J.W. Baars, D.H. Biesma, J.J. Cornellissen, A.J. Croockewit, A.W. Dekker, W.E. Fibbe, B. Löwenberg, M. van Marwijk Kooy, M.H.J. van Oers, D.J. Richel, H.C. Schouten, E. Vellenga, G.E.G. Verhoef, P.W. Weijermans, S. Wittebol and H.M. Lokhorst. Vincristine, doxorubicin and dexamethasone (VAD) administered as rapid intravenous infusion for first-line treatment in untreated Multiple Myeloma. British Journal of Haematology, 105(1), 127-130. 1999.