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Busulfan and Bortezomib Conditioning for High Risk Multiple Myeloma
NCT01534143Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2012
- Primary completion
- May 2013
- Countries
- 1
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Modality
- Small Molecules, Modified Peptides
- Drugs
- bortezomib
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of bortezomib in multiple myeloma (MM), sponsored by Barbara Ann Karmanos Cancer Institute. Primary endpoints: Incidence and Severity of Acute Graft-versus-Host Disease at 6 months, Time to Neutrophil and Platelet Engraftment at 6 months and 2 more. Started Feb 2012; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment Arm
Conditioning with Fludarabine, Busulfan, Bortezomib followed by Allo-HSCT and GVHD prophylaxis
03
Who it enrols
Patients with high-risk multiple myeloma who have progressed after autologous transplant or induction chemotherapy, with adequate organ function and no prior allogeneic transplant.
04
Endpoints
Primary
Incidence and Severity of Acute Graft-versus-Host Disease
Time to Neutrophil and Platelet Engraftment
Treatment Related Mortality
Grade III and IV Non-Hematologic Toxicities
Secondary
Incidence of Myeloma Progression
Transplant Related Mortality and Morbidity
Incidence of Thrombotic Thrombocytopenic Purpura
Incidence of Sinusoidal Obstructive Syndrome
Incidence and Severity of Chronic GVHD
Incidence of Opportunistic Infections
Overall Survival
Progression Free Survival
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