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

Completed

• Conditions: Multiple myeloma.

• Registration Number: NL-OMON20547
• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl

Brief Summary

1. 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; <br> 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; <bR> 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; <br> 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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 452

Inclusion Criteria

At entry:

1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie;

Exclusion Criteria

At entry:

1. Received more than 2 courses of melphalan, prednisone or VMCP;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate.

Secondary Outcome Measures

Name	Time	Method
1. Event-free survival;<br /><br>2. Overall survival;<br /><br>3. Quality of life;<br /><br>4. Cost-benefit.