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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02043847
Collaborator
(none)
12
1
3
32
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Total Marrow Irradiation
  • Drug: Melphalan
  • Drug: Filgrastim (G-CSF)
  • Procedure: Autologous transplant
  • Radiation: Total Marrow Irradiation
  • Drug: Melphalan
  • Drug: Filgrastim (G-CSF)
  • Procedure: Autologous transplant
  • Radiation: Total Marrow Irradiation
  • Drug: Melphalan
  • Drug: Filgrastim (G-CSF)
  • Procedure: Autologous transplant
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.Increasing doses of Total Marrow Irradiation (TMI), 3 Gy, 6 Gy, and 9 Gy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 14, 2014
Actual Primary Completion Date :
Sep 14, 2016
Actual Study Completion Date :
Sep 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1Total Marrow Irradiation (TMI) 3Gy

3Gy with standard high dose melphalan prior to autologous stem cell rescue

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

Drug: Melphalan
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
Other Names:
  • 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 Names:
  • 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

    Experimental: Cohort 2 Total Marrow Irradiation (TMI) 6Gy

    6Gy with standard high dose melphalan prior to autologous stem cell rescue

    Radiation: 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

    Drug: Melphalan
    Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
    Other Names:
  • 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 Names:
  • 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

    Experimental: Cohort 3 Total Marrow Irradiation (TMI) 9Gy

    9Gy with standard high dose melphalan prior to autologous stem cell rescue

    Radiation: 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

    Drug: Melphalan
    Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant
    Other Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose of TMI [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.

    Secondary Outcome Measures

    1. Progression Free Survival [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Illinois Cancer Center Chicago Illinois United States 60612

    Sponsors and Collaborators

    • University of Illinois at Chicago

    Investigators

    • Principal Investigator: Pritesh Patel, MD, University of Illinois at Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pritesh Patel, MD, Faculty, Assistant Professor, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT02043847
    Other Study ID Numbers:
    • 2013-0201
    • 2013-0201
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pritesh Patel, MD, Faculty, Assistant Professor, University of Illinois at Chicago
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2021