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A randomized phase III study on the effect of Thalidomide combined with Adriamycin, Dexamethasone (AD) and High Dose Melphalan in patients with multiple myeloma.

Completed
Conditions
Multiple Myeloma.
Registration Number
NL-OMON27202
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

Haematologica. 2008 Jan;93(1):124-7. <br> <br><br> 2 voorafgaande onderzoeken: <br> <br><br> M.C. Minnema, I. Breitkreutz, J.J. Auwerda, B. van der Holt, F.W. Cremer, A.M. van Marion, P.H. Westveer, P. Sonneveld, H. Goldschmidt and H.M. Lokhorst. Prevention of venous thromboembolism with low molecular-weight heparin in patients with multiple myeloma treated with thalidomide and chemotherapy. Leukemia, 18(12), 2044-2046. 2004<br><br> H. Goldschmidt, P. Sonneveld, F.W. Cremer, B. van der Holt, P. Westveer, I. Breitkreutz, A. Benner, A. Glasmacher, I.G.D. Schmidt-Wolf, H. Martin, D. Hoelzer, A.D. Ho and H.M. Lokhorst. Joint HOVON-50/ GMMG-HD3 randomized trial on the effect of thalidomide as part of a high-dose therapy regimen and as maintenance treatment for newly diagnosed myeloma patients. Annals of Hematology, 82, 654-659. 2003

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
450
Inclusion Criteria

1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;

2. Age 18-65 years inclusive;

Exclusion Criteria

1. Known intolerance of Thalidomide;

2. Systemic AL amyloidosis;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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