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Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma

Phase 2
18 Years
69 Years
Open (Enrolling)
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma


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.


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.


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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From baseline until disease progression, assessed up to 50 years

Safety Issue:


Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109