Trial record 3 of 349 for:    multiple myeloma and autologous transplant

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Illinois at Chicago
Sponsor:
Information provided by (Responsible Party):
Pritesh Patel, MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02043860
First received: January 21, 2014
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Radiation: Total Marrow Irradiation
Procedure: Autologous Transplant
Drug: Melphalan
Drug: Filgrastim (G-CSF)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Maximum tolerated dose of TMI [ Time Frame: Up to 60 days post-transplant (time of engraftment). ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 1 year post-transplant. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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/m2 (100mg/m2 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/m2 (100mg/m2 day-2 and day-1) conditioning therapy prior to transplant.
Other Name: Alkeran ®
Drug: Filgrastim (G-CSF)
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm3 over period of 3 days.
Other Name: Neupogen®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • Durie Salmon stage 2 or 3 disease
    • Abnormal metaphase cytogenetics
    • 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 the following will be ineligible for registration:
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043860

Contacts
Contact: Pritesh Patel, MD 312-996-5762 prpatel8@uic.edu
Contact: Alisha Williams, RN 312-413-2746 alishaw@uic.edu

Locations
United States, Illinois
UIC Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Pritesh Patel, MD    312-996-5762    prpatel8@uic.edu   
Contact: Alisha Williams, RN    312-413-2746    alishaw@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Pritesh Patel, MD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Pritesh Patel, MD, Faculty, Asst. Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02043860     History of Changes
Other Study ID Numbers: 2013-0202
Study First Received: January 21, 2014
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Illinois at Chicago:
Multiple Myeloma
High Risk
Intermediate Risk
Symptomatic

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014