Clinical trial NCT00948922
Conditions: Multiple Myeloma
Keywords: multiple myeloma myeloma myeloma proteins autologous allogeneic G-CSR granulocyte colony-stimulating factor stem cell transplant stem cell stem cell mobilization
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2009-06-18; Completion date: 2019-05-14
Enrollment: 124 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.

Detailed description:
The primary objectives of this study are:

* To determine the 2 year-progression free survival in multiple myeloma with an allogeneic transplant using a conditioning regimen of melphalan + fludarabine + Bortezomib in patients \< 60 years of age and available HLA-matched donor and compare it with the 2 year-progression-free-survival after an autologous stem cell transplant with melphalan+Bortezomib conditioning in patients \< 60 years.
* To determine the 2 year-progression free survival in multiple myeloma with an autologous stem cell transplant using a conditioning regimen of melphalan + Bortezomib. for patients \> 60 years of age and patients \< 60 years of age who decline allogeneic stem cell transplant.

The secondary objectives of this study are:

* To determine the overall survival in multiple myeloma with autologous or allogeneic stem cell transplants using the above conditioning regimens
* To determine the response rates in multiple myeloma using the above regimens.
* To determine minimal residual disease status using allele specific oligonucleotides (ASO-PCR) by PCR and flow-cytometry for multiple myeloma cells.
* To correlate minimal residual disease status with 2 year progression free survival and overall survival.
* To determine the incidence of acute and chronic graft-versus-host disease (GVHD) in multiple myeloma with allogeneic stem cell transplant using the above conditioning regimen.
* To examine quality of life in patients treated with allogeneic and autologous stem cell transplants using the above conditioning regimen.

Arms: arm 1: Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue. arm 2: Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue. arm 3: Group B Expansion on Bortezomib Maintenance: Autologous Only.
Interventions: intervention 1: Bortezomib intervention 2: Melphalan intervention 3: Autologous Stem Cell Transplant intervention 4: Fludarabine intervention 5: Allogeneic Stem Cell Transplant
Intervention descriptions: intervention 1: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion). intervention 2: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes. intervention 3: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells. intervention 4: Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV intervention 5: Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. Allogeneic donor stem cells may also be cryopreserved if they cannot be infused fresh.

Protocol documents:
Prot_SAP_000.pdf: