Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis

February 1, 2013 updated by: Herbert Irving Comprehensive Cancer Center

Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate in patients with multiple myeloma or primary systemic amyloidosis treated with high-dose chemotherapy with autologous hematopoietic stem cell support.
  • Determine the toxicity of this regimen in these patients.
  • Determine the disease-free survival and overall survival of patients with multiple myeloma treated with this regimen.

OUTLINE: Patients are stratified according to disease response to prior treatment (responsive vs refractory or relapsed) and diagnosis (multiple myeloma vs primary systemic amyloidosis).

Following a course of induction chemotherapy, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. Patient who do not mobilize sufficient cells undergo bone marrow harvest.

Patients receive melphalan IV over 30 minutes on days -2 and -1. Half of the stored PBSCs and/or bone marrow is reinfused on day 0. Patients receive sargramostim (GM-CSF) daily beginning on day 0 and continuing until blood counts recover. Patients with primary systemic amyloidosis who are not responding to or are unable to tolerate treatment do not proceed to the second course of therapy.

Within 4-6 weeks after receiving melphalan, patients receive oral busulfan on days -8 to -5 followed by cyclophosphamide IV continuously on days -4 and -3. The remaining half of PBSCs and/or bone marrow is reinfused on day 0. Patients receive GM-CSF daily beginning on day 0 and continuing until blood counts recover.

Within 4-12 weeks after receiving the second course of high-dose chemotherapy, multiple myeloma patients receive maintenance therapy consisting of interferon alfa SC 3 days a week, after blood counts recover.

Patients are followed every 3 months for 1 year and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 60-75 patients (25 for responsive disease stratum, 25 for refractory or relapsed disease stratum, and 10-25 for primary systemic amyloidosis stratum) will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Anticipated)

75

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
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma OR
  • Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life
  • Complete or partial response after standard chemotherapy
  • Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy
  • Ineligible for higher priority national or institutional clinical studies

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2 times normal

Renal:

  • Creatinine less than 2.5 mg/dL or on stable hemodialysis

Cardiovascular:

  • LVEF at least 45%

Pulmonary:

  • DLCO at least 60% of predicted OR
  • Approval by pulmonologist

Other:

  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Concurrent participation in gene therapy trials allowed

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids as antiemetics during chemotherapy
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent barbiturates or acetaminophen during chemotherapy
  • Concurrent participation in supportive care trials allowed

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival at 2 years (patients with responsive disease)

Secondary Outcome Measures

Outcome Measure
Duration of hematologic toxicity
Time to an absolute neutrophil count
Platelet independence

Collaborators and Investigators

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

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Charles S. Hesdorffer, MD, Herbert Irving Comprehensive Cancer 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

July 1, 1999

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068361
  • CPMC-IRB-7328
  • CPMC-CAMP-009
  • NCI-G00-1882

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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