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Trial record 82 of 183 for:    carfilzomib OR pr-171

Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01690143
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : July 10, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Luciano Jose Costa, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Carfilzomib
Drug: Melphalan
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carfilzomib + High Dose Melphalan
Hide Arm/Group Description

Single arm.

Carfilzomib: Subjects will receive the appropriate dose of carfilzomib (according to assigned cohort in phase 1 and at the determined MTD in phase 2) on days -3 and -2. Carfilzomib will be infused over 30 minutes. Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.

Melphalan: Subjects will receive 200 mg/m2 of intravenous melphalan on Day -2. Administered as an intravenous push or a fast infusion according to institutional standard operating procedure (SOP). Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.

Period Title: Overall Study
Started 45
Completed 44
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Carfilzomib + High Dose Melphalan
Hide Arm/Group Description

Single arm.

Carfilzomib: Subjects will receive the appropriate dose of carfilzomib (according to assigned cohort in phase 1 and at the determined MTD in phase 2) on days -3 and -2. Carfilzomib will be infused over 30 minutes. Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.

Melphalan: Subjects will receive 200 mg/m2 of intravenous melphalan on Day -2. Administered as an intravenous push or a fast infusion according to institutional standard operating procedure (SOP). Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
Patients with relapsed multiple myeloma, candidates for autologous hematopoietic cell transplantation
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
58
(41 to 69)
[1]
Measure Description: Time in years from birth to enrollment
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
25
  55.6%
Male
20
  44.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Non-Hispanic Whites
26
  57.8%
Non-Hispanic Blacks
18
  40.0%
Other
1
   2.2%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Carfilzomib Plus Melphalan as Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Relapsed Multiple Myeloma(MM) [Phase I Portion of Study]
Hide Description The maximum tolerated dose of carfilzomib that can be safely combined with high dose melphalan as conditioning regimen prior to autologous hematopoietic cell transplantation in patients with relapsed multiple myeloma meeting eligibility criteria.
Time Frame Up to 4 1/2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent transplantation during phase 1
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description:
All patients who receive transplant in the phase 1 of the study
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg/m2
56
2.Primary Outcome
Title Very Good Partial Response (VGPR) Rate.
Hide Description

VGPR defined as any one of the following:

≥ 90% reduction of serum M-protein; ≥ 90% reduction in 24-hour urinary M-protein or decrease to < 100 mg per 24 hour; ≥ 50% decrease in the difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio; ≥ 50% reduction in bone marrow plasma cells; ≥ 50% reduction in the size of soft tissue plasmacytomas.

Time Frame Up to 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who underwent transplantation
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description:
All patients who receive transplant in the phase 1+2 of the study
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
26
  59.1%
3.Primary Outcome
Title Complete Response (CR) Rate.
Hide Description CR defined as the following: Negative immunofixation of the serum and urine. If only the measurable non-bone marrow parameter was free light chain, normalization of free light chain ratio. < 5% plasma cells in bone marrow. And, disappearance of any soft tissue plasmacytomas.
Time Frame Up to 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description:
All patients who receive transplant in the phase 1+2 of the study
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
10
  22.7%
4.Primary Outcome
Title Median Time for Neutrophil and Platelet Engraftment.
Hide Description Neutrophil engraftment is defined as the first of three consecutive days with absolute neutrophil count >500/mm3. Platelet engraftment is defined as the first of 3 consecutive days of platelets > 20,000/mm3 without platelet transfusion in the prior 7 days.
Time Frame Up to 1 month.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description:
All patients who receive transplant in the phase 1+2 of the study
Overall Number of Participants Analyzed 44
Median (Full Range)
Unit of Measure: days
10
(8 to 16)
5.Primary Outcome
Title Frequency of Grades 3 and 4 Non-hematologic Adverse Events During the Transplant Component ( 135 Days)
Hide Description Grading of AE's is performed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame Up to 4 1/2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description:
All patients who receive transplant in the phase 1+2 of the study
Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
22
  50.0%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Undergoing Transplantation
Hide Arm/Group Description All patients who receive transplant in the phase 1+2 of the study
All-Cause Mortality
Patients Undergoing Transplantation
Affected / at Risk (%)
Total   0/44 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Undergoing Transplantation
Affected / at Risk (%) # Events
Total   1/44 (2.27%)    
Cardiac disorders   
heart failure * 1 [1]  1/44 (2.27%)  1
Renal and urinary disorders   
renal failure * 1 [1]  1/44 (2.27%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Undergoing Transplantation
Affected / at Risk (%) # Events
Total   25/44 (56.82%)    
Cardiac disorders   
hypertension * 1  4/44 (9.09%)  4
Endocrine disorders   
hyperkalemia * 1  3/44 (6.82%)  3
Gastrointestinal disorders   
diarrhea * 1  5/44 (11.36%)  5
Immune system disorders   
rash * 1  3/44 (6.82%)  3
Infections and infestations   
Infection * 1  17/44 (38.64%)  17
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Luciano J Costa, Principal Investigator
Organization: University of Alabama at Birmingham
Phone: 205-209-6038
EMail: ljcosta@uabmc.edu
Layout table for additonal information
Responsible Party: Luciano Jose Costa, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01690143     History of Changes
Other Study ID Numbers: CTO 101669
Onyx IST-CAR-536 ( Other Identifier: Onyx Pharmaceuticals )
First Submitted: July 17, 2012
First Posted: September 21, 2012
Results First Submitted: March 21, 2018
Results First Posted: July 10, 2018
Last Update Posted: August 7, 2018