Status:
TERMINATED
Total Skeletal Irradiation in Multiple Myeloma Before Second Autologous Hematopoietic Stem Cell Transplantation
Lead Sponsor:
University of Rochester
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to improve the efficacy of the HDC regimen by adding a novel, "targeted" means administering a variation of total body irradiation (TBI) radiation i.e., total skeletal irr...
Detailed Description
While HDC/AHSCT is active most patients eventually relapse; obviously, those with lesser responses progress as well. Many investigators regard HDC/AHSCT as a "mature" modality a useful if fixed elemen...
Eligibility Criteria
Inclusion
- Age \</= 70 years
- Documented myeloma confirmed at protocol entry
- Adequate presence of \>/=2.0x10e6/kg cryopreserved CD34+ cells
- Adequate organ function
- Prior therapy is allowed as long as the organ function parameters are maintained and/or excessive radiation exposure is not produced
- Chemosensitivity
Exclusion
- Uncontrolled infection
- Pregnant or lactating females
- Patients in \>/= very good partial response after initial primary non-transplant therapy and/or AHSCT1
- Patients unwilling to practice adequate forms of contraception if clinically indicated
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01182233
Start Date
June 1 2010
End Date
September 1 2014
Last Update
May 17 2016
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642