Back to resultsTotal Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03) (BMT-03)
Primary Purpose
Multiple Myeloma, Relapsed, Multiple Myeloma, Refractory to Standard Treatment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Total Marrow Irradiation
Melphalan
Filgrastim (G-CSF)
Autologous transplant
Total Marrow Irradiation
Melphalan
Filgrastim (G-CSF)
Autologous transplant
Total Marrow Irradiation
Melphalan
Filgrastim (G-CSF)
Autologous transplant
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma, Relapsed focused on measuring Multiple Myeloma, Relapsed, Refractory, Progressive Disease, Symptomatic
Eligibility Criteria
Inclusion Criteria:
- Patients meeting criteria for symptomatic myeloma
- Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- Cardiac function: LVEF >40%
- Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- Renal: Creatinine clearance of >30mL/min, estimated or calculated
- Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Exclusion Criteria:
- Patients with diagnosis of plasma cell leukemia
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Pregnant or breast-feeding
- 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.
- Patients who have undergone prior allogeneic stem cell transplant
- Prior solid organ transplant
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Sites / Locations
- University of Illinois Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1Total Marrow Irradiation (TMI) 3Gy
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
Arm Description
3Gy with standard high dose melphalan prior to autologous stem cell rescue
6Gy with standard high dose melphalan prior to autologous stem cell rescue
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Outcomes
Primary Outcome Measures
Maximum tolerated dose of TMI
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.
Secondary Outcome Measures
Progression Free Survival
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.
Full Information
NCT ID
NCT02043847
First Posted
January 21, 2014
Last Updated
November 20, 2021
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02043847
Brief Title
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
Acronym
BMT-03
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2014 (Actual)
Primary Completion Date
September 14, 2016 (Actual)
Study Completion Date
September 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Relapsed, Multiple Myeloma, Refractory to Standard Treatment
Keywords
Multiple Myeloma, Relapsed, Refractory, Progressive Disease, Symptomatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1Total Marrow Irradiation (TMI) 3Gy
Arm Type
Experimental
Arm Description
3Gy with standard high dose melphalan prior to autologous stem cell rescue
Arm Title
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
Arm Type
Experimental
Arm Description
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Arm Title
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
Arm Type
Experimental
Arm Description
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Intervention Type
Radiation
Intervention Name(s)
Total Marrow Irradiation
Intervention Description
Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran ®
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Intervention Type
Drug
Intervention Name(s)
Filgrastim (G-CSF)
Other Intervention Name(s)
Neupogen®
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous transplant
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Intervention Type
Radiation
Intervention Name(s)
Total Marrow Irradiation
Intervention Description
Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran ®
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Intervention Type
Drug
Intervention Name(s)
Filgrastim (G-CSF)
Other Intervention Name(s)
Neupogen®
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Autologous transplant
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Intervention Type
Radiation
Intervention Name(s)
Total Marrow Irradiation
Intervention Description
Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Intervention Type
Drug
Intervention Name(s)
Melphalan
Other Intervention Name(s)
Alkeran ®
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Intervention Type
Drug
Intervention Name(s)
Filgrastim (G-CSF)
Other Intervention Name(s)
Neupogen®
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Autologous transplant
Intervention Description
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue
Primary Outcome Measure Information:
Title
Maximum tolerated dose of TMI
Description
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.
Time Frame
Up to 60 days post-transplant.
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Up to 1 year post-transplant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients meeting criteria for symptomatic myeloma
Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
Patient age 18-75 years at time of enrollment
Karnofsky performance status of ≥70
Cardiac function: LVEF >40%
Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
Renal: Creatinine clearance of >30mL/min, estimated or calculated
Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
Exclusion Criteria:
Patients with diagnosis of plasma cell leukemia
Patients with truly non secretory myeloma (patients with light chain disease are eligible)
Pregnant or breast-feeding
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.
Patients who have undergone prior allogeneic stem cell transplant
Prior solid organ transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pritesh Patel, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29065747
Citation
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/m2 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.
Results Reference
derived
Learn more about this trial
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)
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