Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00006244

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: aldesleukin Biological: recombinant interferon alfa Drug: melphalan Procedure: in vitro-treated peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Interferon alfa-2a Aldesleukin Interferon alfa-n1 Melphalan Sarcolysin Melphalan hydrochloride Interferons

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date:	February 2000
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine initial response to therapy, time to disease progression, and overall survival of patients with advanced multiple myeloma treated with autologous or syngeneic peripheral blood stem cell transplantation, melphalan, and interleukin-2 followed by interferon alfa.
Compare the toxic effects encountered by patients under age 56 (closed to accrual as of 9/1/03) vs patients age 56 and over treated with this regimen.

OUTLINE: Patients are stratified according to age (18 to 55 [closed to accrual as of 9/1/03] vs 56 and over).

Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of interleukin-2 (IL-2)-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days. Treatment with IL-2 repeats weekly for 4 weeks.

Maintenance therapy begins 1 month after IL-2 treatment. Patients receive interferon alfa subcutaneously 3 times a week in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) (age 18 to 55 stratum closed to accrual as of 9/1/03) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of advanced multiple myeloma meeting 1 of the following staging criteria:
- Diagnosis of stage II or III disease initially
- Stage I disease refractory to or progressed after initial therapy
Meets 1 of the following criteria:
- Has an identical syngeneic twin
- Meets eligibility requirements for mobilization/debulking with cyclophosphamide/etoposide/filgrastim (G-CSF), cyclophosphamide/G-CSF, or cyclophosphamide/paclitaxel/G-CSF (protocol FHCRC-506STP)
No pleural or pericardial effusion or ascites

PATIENT CHARACTERISTICS:

Age:

18 to 69 (age 18 to 55 stratum closed to accrual as of 9/1/03)

Performance status:

Karnofsky 80-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 1.5 mg/dL (unless there is a history of Gilbert's disease)
SGOT or SGPT no greater than 2 times upper limit of normal
Hepatitis C or B negative

Renal:

Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

LVEF at least 50%
No congestive heart disease
No prior myocardial infarction
No coronary artery disease
No prior arrhythmia

Pulmonary:

DLCO at least 60%
FEV1 at least 65% of predicted

Other:

No other malignancies within the past 5 years except basal cell skin cancer or carcinoma in situ
No history of seizures
No active connective tissue disease
No allergy to gentamicin
No hypersensitivity to E. coli-derived preparations
No systemic infection
Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent growth factors

Chemotherapy:

See Disease Characteristics
At least 30 days since prior chemotherapy

Endocrine therapy:

No concurrent corticosteroids

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No concurrent medications (e.g., haloperidol) for controlling mental disorders
No contrast dyes during and for 3 weeks after study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006244

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Leona A. Holmberg, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00006244 History of Changes
Other Study ID Numbers:	1461.00, FHCRC-1461.00, NCI-G00-1845, CDR0000068172
Study First Received:	September 11, 2000
Last Updated:	October 1, 2010
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:

refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:

Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

Interferon-alpha
Interferon Alfa-2a
Interferons
Aldesleukin
Melphalan
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012