Boston, Massachusetts 02118


Purpose:

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.


Study summary:

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.


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 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 is Available At:


Original ID:

CDR0000595782


NCT ID:

NCT00681044


Secondary ID:

BHO-H-25876


Study Acronym:


Brief Title:

HD Melphalan and SCT in Patients With IGDD or LCDD


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Vaishali Sanchorawala, MD
Principal Investigator
Boston Medical Center

Study Dates

Start Date:October 2006
Completion Date:February 2030
Completion Type:Anticipated
Primary Completion Date:October 2015
Primary Completion Type:Anticipated
Verification Date:January 2015
Last Changed Date:January 28, 2015
First Received Date:May 18, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tolerability
Time Frame:100 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:life
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Organ or clinical response
Time Frame:One year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Predictability of early free light-chain response for heme response
Time Frame:One month
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Hematologic response rate
Time Frame:one year
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:filgrastim
Description:16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
Arm Name:SCT with melphalan conditioning
Other Name:G-CSF, neulasta
Intervention Type:Drug
Name:melphalan
Description:70-100 mg/m2/day will be administered intravenously on Days -3 and -2
Arm Name:SCT with melphalan conditioning
Other Name:alkeran
Intervention Type:Procedure
Name:Stem Cell Infusion
Description:infusion of previously collected stem cells on Day 0
Arm Name:SCT with melphalan conditioning

Study Arms

Study Arm Type:Experimental
Arm Name:SCT with melphalan conditioning
Description:Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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