Phase
Condition
Multiple Myeloma
Cancer/tumors
Lymphoproliferative Disorders
Treatment
SIM0500
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation and signature of informed consent form.
≥18 years of age.
Have documented diagnosis of relapsed or refractory multiple myeloma according toCriteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria whohave failed all established standard of care.
Life expectancy ≥12 weeks.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Adequate hematologic, hepatic, and renal function.
Exclusion
Exclusion Criteria:
Toxicities from previous anticancer therapies should have resolved to baselinelevels or to Grade 1 or less except for alopecia or peripheral neuropathy.
Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN)infection; participant with HBsAg positive or detective HBV-DNA at screening shouldreceive antiviral treatment as per local practice during the trial.
Known human immunodeficiency virus (HIV) infection or acquired immunodeficiencysyndrome (AIDS).
Participant is pregnant or breastfeeding, or expecting to conceive or fatherchildren within the projected duration of the trial.
Active known or suspected autoimmune disease. Participants with vitiligo, residualhypothyroidism only requiring hormone replacement, psoriasis not requiring systemictreatment or conditions not expected to recur in the absence of an external trigger,type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can beincluded.
Current or previous other malignancy within 3 years of study entry, except basal orsquamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of theprostate, cervix or breast.
Known active central nervous system (CNS) involvement or exhibits clinical signs ofmeningeal involvement of multiple myeloma.
Participants with known active infection within 14 days prior to the first SIM0500.
Study Design
Connect with a study center
Beijing Chaoyang Hospital Capital Medical University
Beijing, Beijing Municipality 100000
ChinaActive - Recruiting
Beijing Chaoyang Hospital Capital Medical University
Beijing 1816670, Beijing Municipality 2038349 100000
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935 510000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520 450000
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality 300000
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin 1792947, Tianjin Municipality 1792943 300000
ChinaSite Not Available
The First Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang 310000
ChinaActive - Recruiting
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesActive - Recruiting
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Dana Farber Cancer institution
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer institution
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, New York 10029
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available

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