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)



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:July 22, 2015
End Date:September 26, 2020
Contact:Reference Study ID Number: GO29695 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

Use our guide to learn which trials are right for you!

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)

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). Cycle length will be 21 days in Cohorts A to C
and 28 days in Cohorts D to F.


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
(%)

- Total bilirubin
- Creatinine using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min
for those who receive lenalidomide

- Corrected calcium at or below ULN

- Transaminase levels
- Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, E)

- Receipt of 2, but not more that 3 prior lines of therapy that must have included a
proteasome inhibitor (PI) and immunomodulatory drug (IMiD) (alone or in combination,
and are refractory to the last line of treatment(Cohort D2)

- Receipt of >/=2 prior lines of therapy and progressed on treatment with an anti-CD38
monoclonal antibody and are refractory to both a PI and IMiD (Cohort D3)

- Receipt of >/=4 lines of prior therapy and are refractory to the last line of
treatment (Cohort F)

- Absolute neutrophil count (ANC) >/=1000 cells per microliter (cells/mcL) (Cohorts A,
B, D, E, F)

- Platelet count >/=50,000 cells/mcL, or >/=30,000 cells/mcL if more than 50% bone
marrow involvement (Cohorts A, B, D, E, F)

- All participants who are prescribed lenalidomide or pomalidomide must be counseled at
a minimum of every 21-28 days about pregnancy precautions and risks of fetal exposure
(Cohorts B, C, E, F)

- Agree to be registered in and comply with all requirements of the Revlimid Risk
Evaluation and Mitigation Strategy (REMS) program (Cohorts B, C, 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 60-120 days of transplant (Cohort
C)

- Off antibiotic/antifungal therapy for >/=14 days (Cohort C)

- Completion of any prior radiotherapy (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 CD137 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 except for controlled, treated thyroidism or Type 1
diabetes

- Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1

- Prior treatment with chimeric antigen receptor (CAR) T cells or other forms of
adoptive cellular therapy, with the exception of autologous stem cell transplantation

- 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 Cycle 1 Day 1

- Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1

- Prior allogeneic stem cell transplant or solid organ transplant

- Active hepatitis B, active hepatitis C, or positive for 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, C, E, F)

- Evidence of progressive MM compared to pretransplant evaluation (Cohort C)

- Prior treatment with anti-CD38 therapy including daratumumab (Cohorts D1, D2, E, F)
We found this trial at
44
sites
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Little Rock, Arkansas 72202
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1365 Clifton Road
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
330 Brookline Avenue
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
Cary, North Carolina 27513
?
mi
from
Cary, NC
Click here to add this to my saved trials
CHapel Hill, North Carolina 27599
?
mi
from
CHapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Charleston, SC
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
5323 Harry Hines Boulevard
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2799 West Grand Boulevard
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
East Setauket, NY
Click here to add this to my saved trials
?
mi
from
Goshen, IN
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
535 Barnhill Drive
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32224
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Norwalk, Connecticut 06856
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19140
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
335R Prairie Avenue
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
13400 East Shea Boulevard
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials