MINIALO-VELCADE2005: A Study of Bortezomib (Velcade) Treated Multiple Myeloma Patients Pre and Post Allogeneic Haematopoietic Progenitor Cell Transplant With no Myeloablative Conditioning
NCT00564200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2014-10-28
Summary
The primary objective of this study is to analyze the efficacy of allogeneic bone marrow transplantation in a reduced-intensity manner combined with bortezomib in the treatment of multiple myeloma with bad prognosis, in order to evaluate the response and relapse rates
Conditions
Interventions
- DRUG
-
PREACONDICIONAMIENTO: * 2 cycles of 21 days : Velcade days: 1, 4, 8 and 11 * 1 cycle of 13 days : Velcade days 1, 4, 8 and 11 ACONDICIONAMIENTO: \- Day -2: Velcade POSTRANSPLANTATION: * 2 cycles of 21 days : Velcade days 1, 8 and 15 * 5 cycles of 56 days : Velcade days 1, 8 and 15
- DRUG
-
PREACONDICIONAMIENTO: \- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11
- DRUG
-
ACONDICIONAMIENTO: \- Days -9 al -5: Fludarabine
- DRUG
-
Melphalan
ACONDICIONAMIENTO: \- Days -4 and -3: Melphalan.
Sponsors & Collaborators
-
PETHEMA Foundation
lead OTHER
Principal Investigators
-
Bladé Joan, Dr · Hospital Clinic of Barcelona
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 66 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-10-31
Countries
- Spain
Study Locations
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