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Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

RecruitingPhase 1Ages 18 Years - anyAllJiangsu Simcere Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntary participation and signature of informed consent form. 2. ≥18 years of age. 3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care. 4. Life expectancy ≥12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 6. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: 1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. 2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial. 3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial. 5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment 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 be included. 6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 8. Participants with known active infection within 14 days prior to the first SIM0500.
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What it tests

  • SIM0500
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Where

16 sites
Mayo Clinic Arizona
Phoenix, United States
UC Irvine Health
Orange, United States
Mayo Clinic Florida
Jacksonville, United States
Dana Farber Cancer institution
Boston, United States
Mayo Clinic Rochester
Rochester, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, United States
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, United States
University of North Carolina Hospitals at Hillsborough
Hillsborough, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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