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Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma (BMT-02)

Primary Purpose

Multiple Myeloma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Total Marrow Irradiation

Autologous Transplant

Melphalan

Filgrastim (G-CSF)

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, High Risk, Intermediate Risk, Symptomatic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients meeting criteria for symptomatic myeloma
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
Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
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 myeloma who have had any disease progression prior to enrollment
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 allograft or autologous transplant
Prior solid organ transplant
Patients receiving prior radiation to more than 20% of bone marrow containing areas

Sites / Locations

UIC Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total Marrow Irradiation

Arm Description

Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.

Outcomes

Primary Outcome Measures

Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02043860

First Posted

January 21, 2014

Last Updated

September 23, 2019

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT02043860

Brief Title

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

Acronym

BMT-02

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

January 10, 2014 (Actual)

Primary Completion Date

November 7, 2016 (Actual)

Study Completion Date

November 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, High Risk, Intermediate Risk, Symptomatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Total Marrow Irradiation

Arm Type

Experimental

Arm Description

Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.

Intervention Type

Radiation

Intervention Name(s)

Total Marrow Irradiation

Intervention Description

Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.

Intervention Type

Procedure

Intervention Name(s)

Autologous Transplant

Intervention Description

Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.

Intervention Type

Drug

Intervention Name(s)

Melphalan

Other Intervention Name(s)

Alkeran ®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Filgrastim (G-CSF)

Other Intervention Name(s)

Neupogen®

Intervention 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.

Primary Outcome Measure Information:

Title

Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze

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.

Time Frame

Up to 1 year post-transplant.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients meeting criteria for symptomatic myeloma 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 Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months 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 myeloma who have had any disease progression prior to enrollment 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 allograft or autologous transplant Prior solid organ transplant Patients receiving prior radiation to more than 20% of bone marrow containing areas

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pritesh Patel, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

UIC Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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