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Interleukin-12 Treatment for Plateau Phase Multiple Myeloma An Eastern Cooperative Oncology Group Phase II Trial


Interleukin-12 Treatment for Plateau Phase Multiple Myeloma An Eastern Cooperative Oncology Group Phase II Trial



Blood 100(11): Abstract No. 1549



ISSN/ISBN: 0006-4971

Methods: The ECOG conducted a Phase 2 trial of Interleukin-12 (IL-12) for plateau phase multiple myeloma (MM) patients . After enrollment, all patients received vaccinations to haemophilus influenza type B and streptococcus pneumoniae. Patients were then randomly assigned to Arm A or Arm B. Those in Arm A began treatment with IL-12 immediately. Those in Arm B began treatment with IL-12 after waiting a period of 4 weeks. Patients initially were treated with a test dose of IL-12 given I.V. followed two weeks later by IL-12 250 ng/kg I.V daily for 5 days every three weeks for 6-12 cycles. After the first fifteen patients were accrued, the trial was modified due to toxicity to give the IL-12 at a dose of 100 ng/kg BIW for two weeks followed by 300 ng/kg sc BIW for 24 weeks. Blood T cell data was collected from patients at 3 time-points during the study: 1)Baseline (prior to therapy), 2)Four weeks from study registration (Arm A: after 4 weeks of treatment, Arm B: after 4 weeks of observation)and 3)at the end of therapy. What follows is a preliminary report of the results of this trial. Results: The first 15 patients who entered the trial received IL-12 through IV administration only. One patient received three cycles of IL-12 IV and then received the rest of the IL-12 SC while 40 patients received their IL-12 SC. Table below gives the best overall response among those who have completed treatment, are not coded as ineligible and are evaluable for response (N=47). The 3 CR (6.38%) patients remain alive and progression free with 38.0, 27.5 and 6.3 months in response. One was given IL-12 IV, and 2 SC. Of the 31 patients whose best overall response was "No Change", 4 progressed and died, 7 have progressed but are alive and 1 patient died without documented progression. The median time to progression from the start of IL-12 therapy is 11.8 months for the entire group. The median progression-free survival time is 15.0 months for the entire group and 25.9 months among the SC only patients. Median survival has not been reached. Analysis of CD4+ absolute, naive(CD4+/CD45RA+) and activated(CDR4+/CD45RO+)cell levels and naive/activated ratios was done. In Arm A, the only significant difference between time points was a significant increase in the naive/activated ratio between Time 1 and Time 3. In Arm B, there was a significant difference in Naive CD4 count and naive/activated ratio between Time 2 and Time 3, with mean increases per week of 1.526 and 0.01449, respectively. Conclusions: IL-12 therapy in plateau phase MM is associated with improvement in blood immune cells and in clinical responses including CR albeit in a minority of patients. Importantly those achieving CR have had durable remissions.

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