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

No results posted yet for this study

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

Bortezomib

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

dexamethasone

PREACONDICIONAMIENTO: \- 2 cycles of 21 days : Dexamethasone: days 1-4 and 8-11

DRUG

Fludarabine

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564200 on ClinicalTrials.gov