Multiple Myeloma Clinical Trial
Official title:
Phase 2 Multi-center Study of Anti-Programmed-Death-1 [Anti-PD-1] During Lymphopenic State After High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplant [HDT/ASCT] for Multiple Myeloma
Multiple myeloma (MM) is a common incurable blood cancer causing debilitating symptoms-bone
pain, kidney failure, low blood counts and infection. Chemotherapy outcomes are disappointing
due to short-term response and long-term toxicities.
1. Studies showed these patients have weak immune against MM due to the immune checkpoint
mediated by the PD1/PD-L1 interaction between immune cells and MM. Anti-PD-1 antibody
(anti-PD1) disrupts this interaction, thus unleashing immune cell function and leading
to killing of MM cells.
2. Studies further showed enhancement of this "unleash" after autologous transplant and
better MM control by anti-PD1 when used after transplant.
3. Anti-PD1 has been extensively studied in patients with other cancers. It is very safe
and effective and has been FDA-approved. Complications are of mild degree and easy to
manage successfully in out-patient setting. Severe complications are rare.
Thus, investigators proposed an efficacy study of anti-PD1 treatment after transplant to
improve MM treatment outcomes. This was a collaborative study with Medical College of
Wisconsin (headquarter of Center for International blood and Marrow Transplant Research).
Investigators hypothesized that anti-PD1 treatment would increase the MM response and the MM
control duration when added to the standard MM treatment after transplant. Anti-PD1 was given
at the dose and interval, which had been studied previously (200 mg intravenous injection
every 3 weeks) between 2 weeks until 6 months after transplant. Subjects were monitored
closely during and after anti-PD1 therapy until at least 1 year post transplant. Late
complications were followed for 3 years.
n/a
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