Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00185614|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blood Cancer Multiple Myeloma||Procedure: Autologous hematopoietic cell transplant (Auto-HCT) Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT) Drug: Cyclophosphamide Drug: Filgrastim Drug: Melphalan Radiation: Total body irradiation (TBI) Procedure: Cyclosporine (CSP) Drug: Mycophenolate Mofetil (MMF)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2010|
Experimental: Auto- then Allo-HCT
Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue [ie, autologous hematopoietic cells transplant (Auto-HCT)]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 & Day 0, to a target of > 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV & diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
Procedure: Autologous hematopoietic cell transplant (Auto-HCT)
The target cell dose is 2.6 x 10e6 CD34+ cells/kg
Procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
The target cell dose is 5 x 10e6 CD34 cells/kg
Cyclophosphamide administered intravenously (IV) at 4 mg /m² mobilize peripheral blood progenitor cells (PBPC) for autologous re-infusion
Melphalan 200 mg/m2 (high-dose) intravenously as conditioning for Auto-HCT
Radiation: Total body irradiation (TBI)
200 centigray (cGy) total body irradiation delivered on Day 0
Procedure: Cyclosporine (CSP)
Cyclosporine administered twice-daily by mouth at a dose of 6.25 mg/kg from Day -3 through Day 56
Other Name: Cyclosporine A
Drug: Mycophenolate Mofetil (MMF)
Mycophenolate mofetil will begin at 15 mg/kg twice-daily by mouth from Day 0 to Day 27
Other Name: CellCept
- Event-free Survival (EFS) [ Time Frame: 3 years ]Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.
- Relapse Rate [ Time Frame: 3 years ]Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein >25%; bone marrow plasmacytosis >25%; or bone lesions on skeletal survey (any increase).
- Overall Survival (OS) [ Time Frame: 3 years ]Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
- Acute Graft-vs-Host-Disease (aGvHD) [ Time Frame: 6 months ]Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
- Chronic Graft-vs-Host-Disease (cGvHD) [ Time Frame: 3 years ]Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185614
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Wen-Kai Weng, MD||Stanford University|