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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00006244
First received: September 11, 2000
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). 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 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells


Condition Intervention Phase
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
 Drug: melphalan
Biological: recombinant interferon alfa
Biological: aldesleukin
Procedure: in vitro-treated peripheral blood stem cell transplantation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Overall survival [ Time Frame: From baseline until disease progression, assessed up to 50 years ] [ Designated as safety issue: No ]
  • Initial response to therapy (complete response, partial response, or progression of disease) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: From baseline until disease progression, assessed up to 50 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients experiencing grade 3-4 regimen related toxicity [ Time Frame: From baseline until disease progression, assessed up to 50 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2000
Estimated Primary Completion Date: June 2060 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (immunotherapy)
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of 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 followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
 Drug: melphalan
Given IV
Other Names:
  • Alkeran
  • CB-3025
  • L-PAM
  • L-phenylalanine mustard
  • L-Sarcolysin
Biological: recombinant interferon alfa
Given SC
Other Names:
  • Alferon N
  • alpha interferon
  • IFN-A
  • Intron A
  • Roferon-A
Biological: aldesleukin
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Other Names:
  • IL-2
  • Proleukin
  • recombinant human interleukin-2
  • recombinant interleukin-2
Procedure: in vitro-treated peripheral blood stem cell transplantation
Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Other Names:
  • in vitro-treated PBPC transplantation
  • in vitro-treated PBSC
  • in vitro-treated peripheral blood progenitor cell transplantation
  • PBPC transplantation, in vitro-treated
  • peripheral blood progenitor cell transplantation, in vitro-treated

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate initial response to therapy, time to disease progression, and overall survival in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and sequential IL2.

SECONDARY OBJECTIVES:

I. Evaluate grade 3-4 toxicities encountered by younger (< 56 years old) and older (>56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

OUTLINE:

Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of 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 followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of disease progression or unacceptable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Patient must be less than 70 years old
  • Patients with advanced Multiple Myeloma that meet the eligibility requirements for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion; also, if the patients had previously collected PBSC of sufficient number in the past and meet the other eligibility requirements, they may be entered on this study after approval by the PI
  • Patients with advanced Multiple Myeloma that have an identical syngeneic twin for donation of PBSCs
  • Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II or III disease or had stage I disease that progressed after initial therapy or failed to respond to therapy

  • Syngeneic Donor Inclusion:

    • Donor and patient have adequate documentation that donor and recipient are syngeneic; including ABO typing, HLA typing and VNTR studies
    • Donor > 20 kg
    • Donor meets eligibility to donate according to Standard Practice Guidelines

Exclusion Criteria:

  • Patient's age >= 70
  • Karnofsky score less than 80
  • A left ventricular ejection fraction less than 50%; Patients with congestive heart disease, history of myocardial infarction (MI), coronary artery disease or any arrhythmia history
  • Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease)
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2 x upper limit of normal
  • Estimated creatinine clearance < 60 ml/min or creatinine serum > 2.0 mg/dl
  • Pregnancy
  • Seropositivity for human immunodeficiency virus
  • Patients who cannot give informed consent
  • Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in situ within the last five years
  • History of seizures or requirement for medicines, such as haldol, for controlling mental disorders
  • Concurrent need for corticosteroid therapy
  • Active connective tissue disease
  • Pleural effusion, pericardial effusion or ascites
  • Patients allergic to gentamicin
  • Patients with positive PCR for hepatitis C or hepatitis B
  • Patients with hypersensitivity to E. coli - derived preparations
  • Patients with systemic infection at time of IL2 therapy
  • Patients who previously have had more than 50% of their pelvic area irradiated
  • Patients with pulmonary function tests that show diffusion capacity (corrected) < 60%, and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006244

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
National Cancer Institute (NCI)
Investigators
Principal Investigator: Leona Holmberg Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Holmberg, Leona, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT00006244     History of Changes
Other Study ID Numbers: 1461.00, NCI-2011-01313
Study First Received: September 11, 2000
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
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
Interleukin-2
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 May 23, 2013