Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03)

Multiple Myeloma, Refractory to Standard Treatment Clinical Trial

— BMT-03  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043847
• Other study ID #: 2013-0201
• Secondary ID: 2013-0201
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2014
• Est. completion date: September 14, 2016

Study information

• Verified date: November 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 14, 2016
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients meeting criteria for symptomatic myeloma

2. Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)

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

4. Karnofsky performance status of =70

5. Cardiac function: LVEF >40%

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

7. Renal: Creatinine clearance of >30mL/min, estimated or calculated

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

Exclusion Criteria:

1. Patients with diagnosis of plasma cell leukemia

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

3. Pregnant or breast-feeding

4. 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.

5. Patients who have undergone prior allogeneic stem cell transplant

6. Prior solid organ transplant

7. Patients receiving prior radiation to more than 20% of bone marrow containing areas

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma, Refractory to Standard Treatment
• Multiple Myeloma, Relapsed
• Neoplasms, Plasma Cell

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	University of Illinois Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of TMI	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 for relapsed/ refractory myeloma.	Up to 60 days post-transplant.
Secondary	Progression Free Survival	To evaluate 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.	Up to 1 year post-transplant.