HD Melphalan and SCT in Patients With IGDD or LCDD

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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 certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.

Key facts

Study ID

NCT00681044

Run by

Boston Medical Center

People needed

5

Starts

2006-10-01

Expected to finish

2016-01-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Boston University Cancer Research Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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