HD Melphalan and SCT in Patients With IGDD or LCDD

Multiple Myeloma Clinical Trial

Official title:

High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00681044
• Other study ID #: CDR0000595782
• Secondary ID: BHO-H-25876BUMC-
• Status: Terminated
• Phase: Phase 2
• First received: May 18, 2008
• Last updated: January 14, 2016
• Start date: October 2006
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Biological:
• filgrastim
16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC

Drug:
• melphalan
70-100 mg/m2/day will be administered intravenously on Days -3 and -2

Procedure:
• Stem Cell Infusion
infusion of previously collected stem cells on Day 0

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response rate		one year	No
Secondary	Predictability of early free light-chain response for heme response		One month	No
Secondary	Organ or clinical response		One year	No
Secondary	Overall survival		life	No
Secondary	Tolerability		100 days	Yes