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

NCT ID: NCT02043860

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-10
• Study Completion Date: 2016-11-07

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total Marrow Irradiation

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

Group Type: EXPERIMENTAL

Total Marrow Irradiation

Intervention Type: RADIATION

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.

Autologous Transplant

Intervention Type: PROCEDURE

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.

Melphalan

Intervention Type: DRUG

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

Filgrastim (G-CSF)

Intervention Type: 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.

Interventions

Total Marrow Irradiation

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: RADIATION

Autologous Transplant

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: PROCEDURE

Melphalan

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Alkeran ®; Neupogen®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Pritesh Patel, MD

Faculty, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pritesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

UIC Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2013-0202

Identifier Type: OTHER

Identifier Source: secondary_id

2013-0202

Identifier Type: -

Identifier Source: org_study_id