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NCT02043847 · REGISTRY CONDITION SEARCH

TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2024-11-13

In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) of Gy

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    3Gy with standard high dose melphalan prior to autologous stem cell rescue
    intervention Names
    1. Radiation: Total Marrow Irradiation
    2. Drug: Melphalan
    3. Drug: Filgrastim (G-CSF)
    4. Procedure: Autologous transplant
    label
    Cohort 1Total Marrow Irradiation (TMI) 3Gy
    type
    EXPERIMENTAL
  2. description
    6Gy with standard high dose melphalan prior to autologous stem cell rescue
    intervention Names
    1. Radiation: Total Marrow Irradiation
    2. Drug: Melphalan
    3. Drug: Filgrastim (G-CSF)
    4. Procedure: Autologous transplant
    label
    Cohort 2 Total Marrow Irradiation (TMI) 6Gy
    type
    EXPERIMENTAL
  3. description
    9Gy with standard high dose melphalan prior to autologous stem cell rescue
    intervention Names
    1. Radiation: Total Marrow Irradiation
    2. Drug: Melphalan
    3. Drug: Filgrastim (G-CSF)
    4. Procedure: Autologous transplant
    label
    Cohort 3 Total Marrow Irradiation (TMI) 9Gy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1Total Marrow Irradiation (TMI) 3Gy
    description
    Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day
    name
    Total Marrow Irradiation
    type
    RADIATION
  2. arm Group Labels
    1. Cohort 1Total Marrow Irradiation (TMI) 3Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
    name
    Melphalan
    other Names
    1. Alkeran ®
    type
    DRUG
  3. arm Group Labels
    1. Cohort 1Total Marrow Irradiation (TMI) 3Gy
    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.
    name
    Filgrastim (G-CSF)
    other Names
    1. Neupogen®
    type
    DRUG
  4. arm Group Labels
    1. Cohort 1Total Marrow Irradiation (TMI) 3Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    name
    Autologous transplant
    type
    PROCEDURE
  5. arm Group Labels
    1. Cohort 2 Total Marrow Irradiation (TMI) 6Gy
    description
    Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
    name
    Total Marrow Irradiation
    type
    RADIATION
  6. arm Group Labels
    1. Cohort 2 Total Marrow Irradiation (TMI) 6Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
    name
    Melphalan
    other Names
    1. Alkeran ®
    type
    DRUG
  7. arm Group Labels
    1. Cohort 2 Total Marrow Irradiation (TMI) 6Gy
    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
    name
    Filgrastim (G-CSF)
    other Names
    1. Neupogen®
    type
    DRUG
  8. arm Group Labels
    1. Cohort 2 Total Marrow Irradiation (TMI) 6Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    name
    Autologous transplant
    type
    PROCEDURE
  9. arm Group Labels
    1. Cohort 3 Total Marrow Irradiation (TMI) 9Gy
    description
    Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
    name
    Total Marrow Irradiation
    type
    RADIATION
  10. arm Group Labels
    1. Cohort 3 Total Marrow Irradiation (TMI) 9Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
    name
    Melphalan
    other Names
    1. Alkeran ®
    type
    DRUG
  11. arm Group Labels
    1. Cohort 3 Total Marrow Irradiation (TMI) 9Gy
    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
    name
    Filgrastim (G-CSF)
    other Names
    1. Neupogen®
    type
    DRUG
  12. arm Group Labels
    1. Cohort 3 Total Marrow Irradiation (TMI) 9Gy
    description
    Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    name
    Autologous transplant
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
12
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
    measure
    Maximum Tolerated Dose (MTD) of Gy
    time Frame
    Up to 60 days post-transplant.
secondary Outcomes
  1. description
    The disease status of enrolled patients will be evaluated based on the International Myeloma Working Group Criteria. Response Criteria Stringent Complete Response (sCR) in addition to CR all of the following: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. Absence of the original monoclonal paraprotein in the serum or the urine by routine electrophoresis and by immunofixation. The presence of new monoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. No increase in size or number of lytic bone lesions on radiologic investigation (development of compression fracture does not exclude CR and radiographs are not required to document CR if not clinically indicated) 4. Disappearance of soft tissue plasmacytoma
    measure
    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.
Full study description
brief Summary
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
detailed Description
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.
Source references
references
  1. 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.
    pmid
    29065747
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice