A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-001601
    NCT ID: NCT02431208
    Sponsor Protocol Number: GO29695

About this study

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Previous diagnosis of MM with objective evidence of measurable disease
  • Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during Screening and on study
  • Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (
  • Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 40 percent (%)
  • Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D, E)
  • Receipt of >/=3 lines of prior therapy (Cohort F)
  • Absolute neutrophil count (ANC) >/=1000 cells per microliter (cells/mcL) (Cohorts A, B, D, E, F)
  • Transaminase levels
  • Platelet count >/=50,000 cells/mcL (Cohorts A, B, D, E, F)
  • Total bilirubin
  • Creatinine /=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide (Cohorts A, B, D, E, F)
  • Corrected calcium at or below ULN (Cohorts A, B, D, E, F)
  • All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every 21 to 28 days about pregnancy precautions and risks of fetal exposure (Cohorts B, E, F)
  • Agree to be registered in and comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program (Cohorts B and E)
  • Agree to be registered in and comply with all requirements of the Pomalyst REMS program (Cohort F)
  • Sufficient recovery from first or second ASCT within 60 to 120 days of transplant (Cohort C)
  • Off antibiotic/antifungal therapy for >/=14 days (Cohort C)
  • Completion of any prior radiotherapy (Cohort C)
  • Platelet count >/=75,000 cells/mcL (Cohort C)
  • ANC >/=1500 cells/mcL (Cohort C)

Exclusion Criteria:

  • Other malignancy within 2 years prior to Screening, with some exceptions
  • Prior therapy with atezolizumab or other immunotherapies including cluster of differentiation (CD) 137 agonists, anti-programmed death (PD)-1, anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4), and anti-PD-L1 therapeutic antibodies
  • Uncontrolled cancer pain
  • Treatment with any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer
  • Known hypersensitivity to study drug and/or drug class
  • History of autoimmune disease excepted controlled, treated thyroidism or Type 1 diabetes
  • Alkylating agents within 28 days or other anti-cancer therapy within 21 days
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
  • Plasma cell leukemia (greater than 2,000 cells/mcL of circulating plasma cells by standard differential)
  • Immunosuppressive therapy within 6 weeks of treatment initiation
  • Daily corticosteroid requirement within 2 weeks of treatment initiation
  • Prior allogeneic stem cell transplant or solid organ transplant
  • Active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)
  • Uncontrolled, clinically significant pulmonary disease (for example chronic obstructive pulmonary disease, pulmonary hypertension, idiopathic pulmonary fibrosis) that in the opinion of the investigator would put the participant at significant risk for pulmonary complications during the study
  • History of pneumonitis
  • Uncontrolled intercurrent illness including but not limited to uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding females
  • Inability to tolerate thromboprophylaxis (Cohorts B, E, F)
  • Evidence of progressive MM compared to pre-transplant evaluation (Cohort C)
  • Prior treatment with anti-CD38 therapy including daratumumab (Cohorts D, E, F)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Keith Stewart, M.B., Ch.B.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20150035

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