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High-Dose Melphalan and Stem Cell Transplant in Treating Patients With Immunoglobulin Deposition Disease or Light-Chain Deposition Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00681044
First received: May 18, 2008
Last updated: July 21, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Biological: filgrastim
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIGH-DOSE MELPHALAN AND AUTOLOGOUS STEM CELL TRANSPLANTATION (HDM/SCT) IN LIGHT-CHAIN DEPOSITION DISEASE (LCDD) AND IMMUNOGLOBULIN DEPOSITION DISEASE (IGDD)

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Hematologic response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Predictability of early free light-chain response for heme response [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Organ or clinical response [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: life ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Study Completion Date: February 2030
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
    Other Name: G-CSF, neulasta
    Drug: melphalan
    70-100 mg/m2/day will be administered intravenously on Days -3 and -2
    Other Name: alkeran
    Procedure: autologous hematopoietic stem cell transplantation
    infusion of previously collected stem cells on Day 0
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • No overt multiple myeloma, as defined by any of the following:

    • Greater than 30% bone marrow plasmacytosis
    • Extensive (i.e., > 2) lytic lesions
    • Hypercalcemia
  • 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)

PATIENT CHARACTERISTICS:

  • Performance status 0-2
  • LVEF ≥ 45% within the past 90 days
  • 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
  • DLCO ≥ 50%

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681044

Locations
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Vaishali Sanchorawala, MD Boston Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00681044     History of Changes
Other Study ID Numbers: CDR0000595782, BHO-H-25876, BUMC-H-25876
Study First Received: May 18, 2008
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
monoclonal immunoglobulin deposition disease
light chain deposition disease

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Antibodies
Immunoglobulins
Melphalan
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014