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

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02043860
• Other study ID #: 2013-0202
• Secondary ID: 2013-0202
• Status: Terminated
• Phase: Phase 1
• Start date: January 10, 2014
• Est. completion date: November 7, 2016

Study information

• Verified date: September 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 7, 2016
• Est. primary completion date: November 7, 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 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Radiation:
• 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.

Procedure:
• 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.

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.

Locations

Country	Name	City	State
United States	UIC 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	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.	Up to 1 year post-transplant.