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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Charles S. Hesdorffer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068361

NCT ID:

NCT00007995

Start Date:

July 1999

Completion Date:

May 2008

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032