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HD Melphalan and SCT in Patients With IGDD or LCDD

Primary Purpose

Multiple Myeloma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

filgrastim

melphalan

Stem Cell Infusion

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring monoclonal immunoglobulin deposition disease, light chain deposition disease

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Boston University Cancer Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCT with melphalan conditioning

Arm Description

Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion

Outcomes

Primary Outcome Measures

Hematologic Response Rate

Secondary Outcome Measures

Predictability of Early Free Light-chain Response for Heme Response

Organ or Clinical Response

Overall Survival

Tolerability

Full Information

NCT ID

NCT00681044

First Posted

May 18, 2008

Last Updated

March 28, 2017

Sponsor

Boston Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00681044

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

monoclonal immunoglobulin deposition disease, light chain deposition disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCT with melphalan conditioning

Arm Type

Experimental

Arm Description

Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion

Intervention Type

Biological

Intervention Name(s)

filgrastim

Other Intervention Name(s)

G-CSF, neulasta

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

melphalan

Other Intervention Name(s)

alkeran

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Stem Cell Infusion

Intervention Description

infusion of previously collected stem cells on Day 0

Primary Outcome Measure Information:

Title

Hematologic Response Rate

Time Frame

one year

Secondary Outcome Measure Information:

Title

Predictability of Early Free Light-chain Response for Heme Response

Time Frame

One month

Title

Organ or Clinical Response

Time Frame

One year

Title

Overall Survival

Time Frame

life

Title

Tolerability

Time Frame

100 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vaishali Sanchorawala, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Cancer Research Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

HD Melphalan and SCT in Patients With IGDD or LCDD

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