Know Cancer

or
forgot password

HIGH-DOSE MELPHALAN AND AUTOLOGOUS STEM CELL TRANSPLANTATION (HDM/SCT) IN LIGHT-CHAIN DEPOSITION DISEASE (LCDD) AND IMMUNOGLOBULIN DEPOSITION DISEASE (IGDD)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

HIGH-DOSE MELPHALAN AND AUTOLOGOUS STEM CELL TRANSPLANTATION (HDM/SCT) IN LIGHT-CHAIN DEPOSITION DISEASE (LCDD) AND IMMUNOGLOBULIN DEPOSITION DISEASE (IGDD)


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.

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

- No overt multiple myeloma, as defined by any of the following:

- Greater than 30% bone marrow plasmacytosis

- Extensive (i.e., > 2) lytic lesions

- Hypercalcemia

- 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)

PATIENT CHARACTERISTICS:

- Performance status 0-2

- LVEF ≥ 45% within the past 90 days

- 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

- DLCO ≥ 50%

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Vaishali Sanchorawala, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000595782

NCT ID:

NCT00681044

Start Date:

October 2006

Completion Date:

February 2030

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • monoclonal immunoglobulin deposition disease
  • light chain deposition disease
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Boston University Cancer Research CenterBoston, Massachusetts  02118