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Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.


- candidate number1521
- NTR NumberNTR321
- ISRCTNISRCTN82155239
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsHo24 
- Public TitleMyelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.
- Scientific TitleMyelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.
- ACRONYMHOVON 24 MM
- hypothesisThe hypothesis to be tested is that the outcome in arm II (and Allo BMT) is better than in arm I.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease)
- Inclusion criteriaAt 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.
- Exclusion criteriaAt 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-nov-1995
- planned closingdate1-apr-2000
- Target number of participants452
- InterventionsPatients 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.
- Primary outcomeRemission rate.
- Secondary outcome1. Event-free survival;
2. Overall survival;
3. Quality of life;
4. Cost-benefit.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- CONTACT for SCIENTIFIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, CKTO, Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Johnson & Johnson, Roche Nederland BV, Novartis Pharma B.V.
- Publications1. M. van Agthoven, C.M. Segeren, I. Buijt, C.A. Uyl-de Groot, B. van der Holt, H.M. Lokhorst and P. Sonneveld. A cost-utility analysis comparing intensive chemotherapy alone to intensive chemotherapy followed by myeloablative chemotherapy with autologous stem-cell rescue in newly diagnosed patients with stage II/III multiple myeloma; a prospective randomised phase III study. European Journal of Cancer, 40(8), 1159-1169. 2004;
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;
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;
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. L÷wenberg, 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.
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD9-sep-2005 - 20-mei-2008


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