HD Melphalan and SCT in Patients With IGDD or LCDD

March 28, 2017 updated by: Vaishali Sanchorawala, Boston Medical Center

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hematologic Response Rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictability of Early Free Light-chain Response for Heme Response
Time Frame: One month
One month
Organ or Clinical Response
Time Frame: One year
One year
Overall Survival
Time Frame: life
life
Tolerability
Time Frame: 100 days
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

May 18, 2008

First Submitted That Met QC Criteria

May 18, 2008

First Posted (ESTIMATE)

May 20, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000595782
  • BHO-H-25876 (OTHER)
  • BUMC-H-25876 (OTHER: Boston University Medical Center IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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