HD Melphalan and SCT in Patients With IGDD or LCDD
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | October 2006 |
| End Date: | January 2016 |
High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)
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.
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.
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 determine the hematologic response rate in patients treated with this regimen.
- To determine the predictability of early free light-chain response for heme response in
patients treated with this regimen.
- To determine organ or clinical response in patients treated with this regimen.
- To determine overall survival of these patients.
OUTLINE:
- Stem cell mobilization: Patients undergo blood stem cell mobilization comprising
filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before
the last stem cell collection).
- Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells
until the target number of stem cells (at least 2 x 10^6 CD34+ cells) is reached.
- Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
- Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day
0.
After completion of study therapy, patients are followed at 3, 6, and 12 months and then
annually thereafter.
- 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 determine the hematologic response rate in patients treated with this regimen.
- To determine the predictability of early free light-chain response for heme response in
patients treated with this regimen.
- To determine organ or clinical response in patients treated with this regimen.
- To determine overall survival of these patients.
OUTLINE:
- Stem cell mobilization: Patients undergo blood stem cell mobilization comprising
filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before
the last stem cell collection).
- Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells
until the target number of stem cells (at least 2 x 10^6 CD34+ cells) is reached.
- Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
- Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day
0.
After completion of study therapy, patients are followed at 3, 6, and 12 months and then
annually thereafter.
Inclusion Criteria:
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 IHC
- 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
- LVEF ≥ 45% within the past 90 days
- DLCO ≥ 50%
Exclusion Criteria:
- 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
We found this trial at
1
site
72 East Concord St.
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617-638-4173
Boston University Cancer Research Center
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