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Completed

NCT Number: NCT02043847

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

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.

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Key information

Conditions

Multiple Myeloma, Relapsed Blood Protein Disorders Cardiovascular Diseases Disease Attributes Disease Progression Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma, Refractory to Standard Treatment Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total marrow irradiation

Radiation

Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day

melphalan

Drug

Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant

Other names: Alkeran ®

Filgrastim (G-CSF)

Drug

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®

Autologous transplant

Procedure

Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of Gy

    Time frame: Up to 60 days post-transplant.

    Assessing MTD of TMI of 3Gy, 6Gy and 9Gy

Secondary outcomes

  1. 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.

    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:

    • Normal free light chain ratio (FLC)
    • Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed

    Complete Response (CR) requires all of the following:

    • 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.
    • Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed.
    • 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)
    • Disappearance of soft tissue plasmacytoma

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study 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

Acronym: BMT-03

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2014
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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