Status:
TERMINATED
HD Melphalan and SCT in Patients With IGDD or LCDD
Lead Sponsor:
Boston Medical Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and cert...
Detailed Description
OBJECTIVES: * To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease. * To det...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed light-chain deposition disease based on the following criteria:
- Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
- Evidence of a plasma cell dyscrasia, as defined by any of the following:
- Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis
- Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical
- Elevated serum levels of FLC
- Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10\^6 cells available for transplantation)
- PRIOR CONCURRENT THERAPY:
- Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes
- Prior total dose of melphalan \< 300 mg
- More than 4 weeks since prior cytotoxic therapy and recovered
- PATIENT CHARACTERISTICS:
- Performance status 0-2
- Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days
- diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50%
Exclusion
- No overt multiple myeloma, as defined by any of the following:
- Greater than 30% bone marrow plasmacytosis
- Extensive (i.e., \> 2) lytic lesions
- Hypercalcemia
- No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
- No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years
- No HIV positivity
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00681044
Start Date
October 1 2006
End Date
January 1 2016
Last Update
April 28 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118