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

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ClinicalTrials.gov Identifier: NCT02043847
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pritesh Patel, MD, University of Illinois at Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma, Relapsed Multiple Myeloma, Refractory to Standard Treatment Radiation: Total Marrow Irradiation Drug: Melphalan Drug: Filgrastim (G-CSF) Procedure: Autologous transplant Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 14, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, or 9Gy) with standard high dose melphalan prior to autologous stem cell rescue.
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. Total IMT doses: 3Gy, 6Gy, or 9Gy.

Drug: Melphalan
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 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/mm^3 over period of 3 days.
Other Name: Neupogen®

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.




Primary Outcome Measures :
  1. Maximum tolerated dose of TMI [ Time Frame: Up to 60 days post-transplant. ]
    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.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 1 year post-transplant. ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043847


Locations
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United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Pritesh Patel, MD University of Illinois at Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pritesh Patel, MD, Faculty, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02043847     History of Changes
Other Study ID Numbers: BMT-03
2013-0201 ( Other Identifier: University of Illinois at Chicago (UIC) Office for the Protection of Research Subjects (OPRS) )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pritesh Patel, MD, University of Illinois at Chicago:
Multiple Myeloma
Relapsed
Refractory
Progressive Disease
Symptomatic

Additional relevant MeSH terms:
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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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs