Total Skeletal Irradiation in Multiple Myeloma Before Second Autologous Hematopoietic Stem Cell Transplantation
Stopped early · Phase 1
Conditions studied: Multiple Myeloma
In brief
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 irradiation (TSI) administered by helical tomotherapy (HT) before, and in addition to the current standard of HDC, at a dose of 200 mg/m2 (HDMel200). The underlying postulate of this endeavor is that TSI-HT will provide additional cytoreduction to HDMel alone, without producing additional (serious) toxicity. We will utilize a classical Phase I study design (i.e., dose escalation) in myeloma patients undergoing AHSCT2 to define a maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Finally, although comparisons to other therapies are not typical (and/or feasible) for a Phase I study, we will compare, whenever possible, both the toxicity and the antimyeloma activity of the AHSCT2 to AHSCT1. This protocol will standardize, as much as possible the use of AHSCT2 both as a "tandem" and "salvage" procedure. Since sufficient AHSC (CD34+ cells) are routinely collected in adequate numbers for multiple AHSCTs, but recently used infrequently, it is important to work towards defining the optimal utilization of this resource.
Key facts
- Study ID
- NCT01182233
- Run by
- University of Rochester
- People needed
- 4
- Starts
- 2010-06-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-05-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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