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Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma


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

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Trial Information

Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma


OBJECTIVES:

Primary

- To assess the clinical benefit in patients with plateau phase multiple myeloma treated
with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous
dendritic cell vaccine APC8020.

- To describe response rates in patients who are in plateau phase status
post-chemotherapy or status post-peripheral blood cell transplantation treated with
this regimen.

Secondary

- To obtain data regarding the ability of this approach to produce an anti-idiotypic
immunologic response.

- To obtain information about the effects of interferon-gamma and aldesleukin on the
number, function, and activation state of immune effector-cells including T-cells and
B-cells.

- To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and
after idiotype-pulsed autologous dendritic cell vaccine APC8020.

OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment
(post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are
randomized to 1 of 2 arms.

In both arms, patients undergo apheresis for collection of peripheral blood mononuclear
cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by
loading DC with immunoglobulin idiotype prepared from the patient's serum.

- Arm I: Patients receive interferon-gamma subcutaneously (SC) once daily on days 1-5,
15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 IV over
30-minutes on days 2, 16, and 30.

- Arm II: Patients receive aldesleukin SC once daily days 1-5, 15-20, and 29-34 and
idiotype-pulsed autologous dendritic cell vaccine APC8020 as in arm I.

In both arms, treatment continues in the absence of disease progression.

Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for
cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic
markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and
immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype
protein; and CTL and T-helper response by flow cytometry.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma

- Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral
blood cell transplantation), meeting the following criteria:

- Serum and urine monoclonal (M) protein values must be stable (< 20% variation)
or must have disappeared

- Serum M protein < 1 g/dL, and 1 of the following:

- Quantifiable serum M protein

- Adequate serum sample stored in Transfusion Medicine under IRB protocol
#698-98

- Urine M protein < 200 mg/24 hours by electrophoresis on 2 separate occasions for
a period of ≥ 4 weeks

- Serum M protein spike ≤ 2.0 g/dL

- No progressive disease after prior autologous stem cell transplantation or
chemotherapy

- No non-secretory or light chain myeloma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- WBC ≥ 1,500/μL

- Platelet count ≥ 50,000/μL

- Total bilirubin ≤ 5 times upper limit of normal

- Creatinine ≤ 5.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must have adequate venous access for apheresis

- No uncontrolled cardiac disease

- No uncontrolled infection

- No illness or condition which, in the opinion of the investigator, may affect safety
of treatment or evaluation of any of the study's endpoints

PRIOR CONCURRENT THERAPY:

- Recovered from all prior therapy

- More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or
immunotherapy

- More than 3 months since prior high-dose chemotherapy with stem cell transplantation

- No concurrent corticosteroids

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Confirmed response (i.e., clinical or immunological)

Safety Issue:

No

Principal Investigator

Martha Q. Lacy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000582566

NCT ID:

NCT00616720

Start Date:

August 2001

Completion Date:

November 2007

Related Keywords:

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

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