Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
- 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
- To obtain data regarding the ability of this approach to produce an anti-idiotypic
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Confirmed response (i.e., clinical or immunological)
Martha Q. Lacy, MD
United States: Food and Drug Administration