TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
NCT ID: NCT02043847
Last Updated: 2024-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2014-01-14
2016-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
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
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation
Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation
Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Interventions
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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
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Total Marrow Irradiation
Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Total Marrow Irradiation
Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Damiano Rondelli, MD
Professor
Principal Investigators
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Damiano Rondelli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois Cancer Center
Chicago, Illinois, United States
Countries
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References
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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.
Other Identifiers
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2013-0201
Identifier Type: OTHER
Identifier Source: secondary_id
2013-0201
Identifier Type: -
Identifier Source: org_study_id
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