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

Summary

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.

Conditions

• Multiple Myeloma, Relapsed
• Multiple Myeloma, Refractory to Standard Treatment

Interventions

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

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.

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

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

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

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

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

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

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

Sponsors & Collaborators

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Damiano Rondelli, MD · University of Illinois at Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-14

Primary Completion

2016-09-14

Completion

2016-09-14

FDA Drug

Yes

Countries

• United States

Study Locations