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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

A Phase Ib Study of the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Patients With Multiple Myeloma (Relapsed/Refractory and Post-Autologous Stem Cell Transplantation)

Keywords

Multiple Myeloma Lenalidomide Thalidomide Antibodies Immunoglobulins Antibodies, Monoclonal Pomalidomide Daratumumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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)

Locations

  • Scripps Clinic Torrey Pines not yet accepting patients
    La Jolla, California, 92037, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02431208
Phase
Phase 1
Lead Scientist
Thomas Martin
Study Type
Interventional
Last Updated
April 2017
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