Know Cancer

or
forgot password

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)
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

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


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.


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:

Interventional

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:

No

Principal Investigator

Leona Holmberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

1461.00

NCT ID:

NCT00006244

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

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109