Phase 2 Multi-center Study of Anti-PD-1 During Lymphopenic State After HDT/ASCT for Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT02331368
Run by: University of Michigan Rogel Cancer Center
People needed: 32
Starts: 2015-06-01
Expected to finish: 2017-06-01
Last updated by the study team: 2018-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with MM (Multiple Myeloma) of any stage
Has no Progressive Disease (PD) AND has suboptimal response with primary therapy
Has measurable disease
Has no prior hematopoietic stem cell transplant of any type
Has performance status of 0 or 1 (Eastern Cooperative Oncology, ECOG, Performance Scale)
Has had a successful peripheral blood stem cell collection with G-CSF (Filgrastim) +/- Plerixafor (Mozobil) only
Be willing and able to provide written informed consent
Female subjects of child bearing age should have negative urine or serum pregnancy test
Female subjects of child bearing age must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity
Male subjects must agree to use an adequate method of contraception
Subject must be able to swallow capsules
Must demonstrate adequate organ function

You may not qualify if…

Has history of repeat infections, amyloidosis, hyperviscosity, plasma cell leukemia, POEMS syndrome, Waldenstrom's macroglobulinemia, non-secretory multiple myeloma, or IgM myeloma
Has known CNS (Central Nervous System) involvement or history of resolved CNS involvement
Has an active autoimmune disease or history of autoimmune disease that requires systemic treatment with steroids of immunosuppressive agents.
Has active, non-infectious pneumonitis
Has diagnosis of immunosuppressive disorder or on immunosuppressive therapy within 7 days of transplant admission
Is currently participating in or has previously participated in the study of an investigational drug/device within 4 weeks of transplant admission
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4
Has had prior monoclonal antibody, chemotherapy, small molecule therapy, or radiation within 2 weeks of transplant admission
Has not recovered from adverse events due to previously administered agent
Must be free of additional malignancy for at least 5 years
Has an active infection requiring systemic therapy
Has known psychiatric or substance abuse disorders that would interfere with requirements of the study
Is pregnant or breastfeeding or expecting to conceive
Has known HIV, Hepatitis B, or Hepatitis C infection
Has clinically significant coagulopathy
Has known symptomatic heart failure, unstable angina pectoris, or cardiac arrhythmia
Has received any type of hematopoietic cell transplant
Has received a live vaccine within 30 days of transplant admission
Is or has an immediate family member whos is investigational site or sponsor staff directly involved with this study

Where it is running

University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.