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Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03) (BMT-03)

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ClinicalTrials.gov Identifier: NCT02043847
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pritesh Patel, MD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE January 14, 2014
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
Maximum tolerated dose of TMI [ Time Frame: Up to 60 days post-transplant. ]
To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant for relapsed/ refractory myeloma.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02043847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
Progression Free Survival [ Time Frame: Up to 1 year post-transplant. ]
To evaluate progression free survival (PFS) and in patients with multiple myeloma (relapsed or refractory) undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Official Title  ICMJE BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 9Gy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma, Relapsed
  • Multiple Myeloma, Refractory to Standard Treatment
Intervention  ICMJE
  • Radiation: Total Marrow Irradiation
    Subjects in this trial will receive total marrow irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, or 9Gy.
  • Drug: Melphalan
    Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant.
    Other Name: Alkeran ®
  • Drug: Filgrastim (G-CSF)
    Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.
    Other Name: Neupogen®
  • Procedure: Autologous transplant
    Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue.
Study Arms  ICMJE Experimental: Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, or 9Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Interventions:
  • Radiation: Total Marrow Irradiation
  • Drug: Melphalan
  • Drug: Filgrastim (G-CSF)
  • Procedure: Autologous transplant
Publications * Patel P, Oh AL, Koshy M, Sweiss K, Saraf SL, Quigley JG, Khan I, Mahmud N, Hacker E, Ozer H, Peace DJ, Weichselbaum RR, Aydogan B, Rondelli D. A phase 1 trial of autologous stem cell transplantation conditioned with melphalan 200 mg/m(2) and total marrow irradiation (TMI) in patients with relapsed/refractory multiple myeloma. Leuk Lymphoma. 2018 Jul;59(7):1666-1671. doi: 10.1080/10428194.2017.1390231. Epub 2017 Oct 25.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
18
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients meeting criteria for symptomatic myeloma
  2. Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
  3. Patient age 18-75 years at time of enrollment
  4. Karnofsky performance status of ≥70
  5. Cardiac function: LVEF >40%
  6. Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
  7. Renal: Creatinine clearance of >30mL/min, estimated or calculated
  8. Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

Exclusion Criteria:

  1. Patients with diagnosis of plasma cell leukemia
  2. Patients with truly non secretory myeloma (patients with light chain disease are eligible)
  3. Pregnant or breast-feeding
  4. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
  5. Patients who have undergone prior allogeneic stem cell transplant
  6. Prior solid organ transplant
  7. Patients receiving prior radiation to more than 20% of bone marrow containing areas
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 NCT02043847
Other Study ID Numbers  ICMJE 2013-0201
2013-0201 ( Other Identifier: University of Illinois at Chicago (UIC) Office for the Protection of Research Subjects (OPRS) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pritesh Patel, MD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pritesh Patel, MD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date September 2019

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