HD Melphalan and SCT in Patients With IGDD or LCDD

NCT ID: NCT00681044

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2016-01-31

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 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.

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 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 cluster of differentiation-34-positive 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCT with melphalan conditioning

Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC

melphalan

Intervention Type: DRUG

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

Stem Cell Infusion

Intervention Type: PROCEDURE

infusion of previously collected stem cells on Day 0

Interventions

filgrastim

16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC

Intervention Type: BIOLOGICAL

melphalan

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

Intervention Type: DRUG

Stem Cell Infusion

infusion of previously collected stem cells on Day 0

Intervention Type: PROCEDURE

Other Intervention Names

G-CSF, neulasta; alkeran

Eligibility Criteria

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 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Vaishali Sanchorawala

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vaishali Sanchorawala, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston University Cancer Research Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

BHO-H-25876

Identifier Type: OTHER

Identifier Source: secondary_id

BUMC-H-25876

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000595782

Identifier Type: -

Identifier Source: org_study_id