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Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

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ClinicalTrials.gov Identifier: NCT00793650
Recruitment Status : Terminated
First Posted : November 19, 2008
Results First Posted : June 18, 2012
Last Update Posted : August 30, 2012
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Sagar Lonial, Emory University

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 19, 2008
Results First Submitted Date  ICMJE March 14, 2012
Results First Posted Date  ICMJE June 18, 2012
Last Update Posted Date August 30, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
Safety and Engraftment [ Time Frame: Day 30 after transplant ]
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Safety and Engraftment [ Time Frame: Day 30 after transplant ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant. [ Time Frame: 100 days after transplant ]
CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour. Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Response rate using EBMT criteria at Day +100 after transplant [ Time Frame: 100 days after transplant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
Official Title  ICMJE Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
Brief Summary The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Multiple Myeloma
Intervention  ICMJE
  • Drug: Bortezomib
    Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
    Other Name: Bortezomib or Velcade
  • Drug: Melphalan

    All patients received melphalan (100 mg/m^2/day × 2; days

    −3 and −2), for a total dose of 200 mg/m^2.

    Other Name: Bortezomib or Velcade
  • Procedure: Autologous PBSC Transplant
    Day 0 consists of the stem cell infusion.
Study Arms  ICMJE
  • Active Comparator: Bortezomib before Melphalan
    Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan.
    Interventions:
    • Drug: Bortezomib
    • Drug: Melphalan
    • Procedure: Autologous PBSC Transplant
  • Active Comparator: Bortezomib after Melphalan
    Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
    Interventions:
    • Drug: Bortezomib
    • Drug: Melphalan
    • Procedure: Autologous PBSC Transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2012)
39
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
40
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant
  • Male and female subjects between the age of 18 and 70 years.
  • Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male subjects agrees to use an acceptable method for contraception for the duration of the study.
  • Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation
  • Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow.
  • Karnofsky Performance Status score of ≥ 60%
  • Patient has met the following laboratory requirements prior to Day -4
  • Platelet count ≥ 50, 000/mm3
  • Absolute Neutrophil Count ≥ 500/mm3
  • Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)
  • Calculated creatinine clearance ≥ 30mL/min
  • Toxic effects of previous therapy or surgery resolved to Grade 2 or better

Exclusion Criteria:

  • Unsupportable anemia with < 10b/dL
  • Patient has a calculated or measured creatinine clearance of < 30mL/min within 14 days before enrollment
  • Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment
  • Patient has hypersensitivity to bortezomib, boron or mannitol
  • Patient has had an allergic reaction to melphalan or chlorambucil
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria
  • Known central nervous system involvement or suspicion of involvement with Myeloma
  • Other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. Patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion.
  • Known to be HIV positive, HIV-1 positive
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793650
Other Study ID Numbers  ICMJE 080-2005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sagar Lonial, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Sagar Lonial, MD Emory University Winship Cancer Institute
PRS Account Emory University
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP