Clinical Trials /

Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma

NCT02043860

Description:

In this phase I trial, patients with 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 12Gy.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
  • Official Title: BMT-02: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Multiple Myeloma Following Initial Induction Therapy

Clinical Trial IDs

  • ORG STUDY ID: BMT-02
  • SECONDARY ID: 2013-0202
  • NCT ID: NCT02043860

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
MelphalanAlkeran ®Total Marrow Irradiation
Filgrastim (G-CSF)Neupogen®Total Marrow Irradiation

Purpose

In this phase I trial, patients with 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 12Gy.

Trial Arms

NameTypeDescriptionInterventions
Total Marrow IrradiationExperimentalEscalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
  • Melphalan
  • Filgrastim (G-CSF)

Eligibility Criteria

        Inclusion Criteria:

          1. Patients meeting criteria for symptomatic myeloma

          2. Patients must be high or intermediate risk of disease progression as defined by having
             one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase
             cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy

          3. Patients who have received at least 2 cycles of systemic treatment of any kind in the
             preceding 12 months

          4. Patient age 18-75 years at time of enrollment

          5. Karnofsky performance status of ≥70

          6. Cardiac function: LVEF >40%

          7. Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of
             normal

          8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated

          9. Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)

        Exclusion Criteria:

          1. Patients with diagnosis of plasma cell leukemia

          2. Patients with myeloma who have had any disease progression prior to enrollment

          3. Patients with truly non secretory myeloma (patients with light chain disease are
             eligible)

          4. Pregnant or breast-feeding

          5. 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.

          6. Patients who have undergone prior allograft or autologous transplant

          7. Prior solid organ transplant

          8. Patients receiving prior radiation to more than 20% of bone marrow containing areas
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose of TMI
Time Frame:Up to 60 days post-transplant (time of engraftment).
Safety Issue:
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.

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:Up to 1 year post-transplant.
Safety Issue:
Description:To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:University of Illinois at Chicago

Trial Keywords

  • Multiple Myeloma
  • High Risk
  • Intermediate Risk
  • Symptomatic

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