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Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185614
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Wen-Kai Weng, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Blood Cancer
Multiple Myeloma
Interventions 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)
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description 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.
Period Title: Autologous HCT (Auto-HCT)
Started 63
Completed 63
Not Completed 0
Period Title: Inter-treatment Period
Started 63 [1]
Completed 59
Not Completed 4
Reason Not Completed
Physician Decision             1
Relapse             2
Lack of allogenic donor             1
[1]
Not all participants who received autologous transplant continued to receive allogeneic transplant.
Period Title: Allogenic HCT (Allo-HCT)
Started 59
Completed 59
Not Completed 0
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  95.2%
>=65 years
3
   4.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
20
  31.7%
Male
43
  68.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Hispanic or Latino
5
   7.9%
Not Hispanic or Latino
43
  68.3%
Unknown or Not Reported
15
  23.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  11.1%
Native Hawaiian or Other Pacific Islander
3
   4.8%
Black or African American
5
   7.9%
White
43
  68.3%
More than one race
0
   0.0%
Unknown or Not Reported
5
   7.9%
1.Primary Outcome
Title Event-free Survival (EFS)
Hide Description 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.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
Auto-HCT only Number Analyzed 4 participants
0
   0.0%
Auto-HCT then Allo-HCT Number Analyzed 59 participants
24
  40.7%
All Participants Number Analyzed 63 participants
24
  38.1%
2.Secondary Outcome
Title Relapse Rate
Hide Description 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).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data are reported as the number of participants who relapse per criteria within 3 years.
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Auto-HCT only Number Analyzed 4 participants
2
Auto-HCT then Allo-HCT Number Analyzed 59 participants
29
All Participants Number Analyzed 63 participants
31
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) as determined for all participants who received the initial Auto-HCT treatment, as assessed from the date of the last transplant.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome data are reported as the number of participants who could be documented as remaining alive through 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Auto-HCT only Number Analyzed 4 participants
1
Auto-HCT then Allo-HCT Number Analyzed 59 participants
41
All Participants Number Analyzed 63 participants
42
4.Secondary Outcome
Title Acute Graft-vs-Host-Disease (aGvHD)
Hide Description Development of acute graft-vs-host-disease (aGvHD) within 6 months, for participants receiving Allo-HCT.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT, as determined by investigator judgement (no protocol-specified criteria).
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.9%
5.Secondary Outcome
Title Chronic Graft-vs-Host-Disease (cGvHD)
Hide Description 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).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.
Arm/Group Title Auto- Then Allo-HCT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
Extensive cGvHD
30
  50.8%
cGvHD, not Extensive
8
  13.6%
No cGvHD
21
  35.6%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants Receviing at Least Auto-HCT
Hide Arm/Group Description 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.
All-Cause Mortality
All Participants Receviing at Least Auto-HCT
Affected / at Risk (%)
Total   21/63 (33.33%)    
Hide Serious Adverse Events
All Participants Receviing at Least Auto-HCT
Affected / at Risk (%) # Events
Total   63/63 (100.00%)    
Blood and lymphatic system disorders   
Coagulase-negative staphylococci * 1  3/63 (4.76%)  3
Fungemia * 1  1/63 (1.59%)  1
Gram-negative bacillary bacteremia * 1  6/63 (9.52%)  6
Hyponatremia * 1  1/63 (1.59%)  1
Platelet count decrease * 1  3/63 (4.76%)  4
Pseudomonas bacteremia * 1  1/63 (1.59%)  1
Cardiac disorders   
Heart Failure * 1  1/63 (1.59%)  1
Cardiopulmonary Failure * 1  2/63 (3.17%)  2
Supraventricular tachycardia * 1  1/63 (1.59%)  1
Superior Vena Cava Syndrome * 1  1/63 (1.59%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/63 (3.17%)  2
Erosive esophagitis * 1  1/63 (1.59%)  1
Mucositis * 1  8/63 (12.70%)  8
Nausea * 1  4/63 (6.35%)  4
Immune system disorders   
Cytomegalovirus * 1  2/63 (3.17%)  2
Infections and infestations   
Bacteremia * 1  2/63 (3.17%)  2
Febrile Neutropenia * 1  31/63 (49.21%)  31
Fever * 1  3/63 (4.76%)  3
Klebsiella bacteremia * 1  1/63 (1.59%)  1
Pneumonia * 1  2/63 (3.17%)  2
Viral Pneumonitis * 1  1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders   
Myopathy * 1  1/63 (1.59%)  1
Rhabdomyositis * 1  1/63 (1.59%)  1
Right Parietal Encephalocele * 1  1/63 (1.59%)  1
Nervous system disorders   
Herpetic stomatitis * 1  1/63 (1.59%)  1
Psychiatric disorders   
Aseptic Encephalitis * 1  1/63 (1.59%)  1
Renal and urinary disorders   
Acute Kidney Injury * 1  1/63 (1.59%)  1
Renal Failure * 1  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Lung Aspergillosis * 1  1/63 (1.59%)  1
Pulmonary Failure * 1  3/63 (4.76%)  3
Lung Aspergillosis * 1  1/63 (1.59%)  2
Respiratory syncytial virus pneumonitis * 1  5/63 (7.94%)  5
Skin and subcutaneous tissue disorders   
Disseminated varicella zoster * 1  4/63 (6.35%)  4
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants Receviing at Least Auto-HCT
Affected / at Risk (%) # Events
Total   63/63 (100.00%)    
Blood and lymphatic system disorders   
Coagulase-negative staphylococci * 1  1/63 (1.59%)  1
Neutropenia * 1  16/63 (25.40%)  17
Platelet count decrease * 1  14/63 (22.22%)  15
Transaminitis * 1  1/63 (1.59%)  1
Thrombotic Thrombocytopenic Purpura * 1  2/63 (3.17%)  2
Gastrointestinal disorders   
Colitis * 1  1/63 (1.59%)  1
Diarrhea * 1  1/63 (1.59%)  1
Gastritis * 1  1/63 (1.59%)  1
Mucositis * 1  6/63 (9.52%)  6
Nausea * 1  7/63 (11.11%)  7
Steroid Myopathy * 1  1/63 (1.59%)  1
General disorders   
Dehyration * 1  1/63 (1.59%)  1
Immune system disorders   
Cytomegalovirus * 1  5/63 (7.94%)  6
Infections and infestations   
Bacteremia * 1  1/63 (1.59%)  1
Clostridium Difficile Colitis * 1  2/63 (3.17%)  2
Febrile neutropenia * 1  5/63 (7.94%)  5
Fever * 1  2/63 (3.17%)  2
Parainfluenza pneumonitis * 1  1/63 (1.59%)  1
Viral Pneumonitis * 1  1/63 (1.59%)  1
Nervous system disorders   
Herpes Zoster * 1  1/63 (1.59%)  1
Renal and urinary disorders   
Acute Kidney Injury * 1  1/63 (1.59%)  1
Ascites * 1  1/63 (1.59%)  1
Renal Failure * 1  15/63 (23.81%)  16
Respiratory, thoracic and mediastinal disorders   
Viral bronchitis * 1  1/63 (1.59%)  1
Skin and subcutaneous tissue disorders   
Cellulitis * 1  1/63 (1.59%)  1
Disseminated varicella zoster * 1  2/63 (3.17%)  2
Maculo-papular rash * 1  6/63 (9.52%)  6
Seborrheic dermatitis * 1  1/63 (1.59%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wen-Kai Weng, MD; Associate Professor of Medicine
Organization: Stanford University School of Medicine
Phone: 650-723-7689
EMail: wkweng@stanford.edu
Layout table for additonal information
Responsible Party: Wen-Kai Weng, Stanford University
ClinicalTrials.gov Identifier: NCT00185614    
Other Study ID Numbers: IRB-13378
75190 ( Other Identifier: Stanford University Alternate IRB Approval No. )
BMT109 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: October 31, 2017
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018