Trial NCT06375044
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
6. Adequate hematologic, hepatic, and renal function.Hepatic · Renal
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).HIV
4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.Pregnancy
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.Prior malignancy
7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.Brain metastases
8. Participants with known active infection within 14 days prior to the first SIM0500.
Restrictions found (7)
- Brain metastasesConditionalexclusionShow in the text
- HepaticConditionalinclusion
adequate
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusConditionalinclusion
ECOG 0 or 1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
within 3 years
Show in the text - RenalConditionalinclusion
adequate
Show in the text
Recruiting in Massachusetts
- Dana Farber Cancer institution · Boston, Suffolk County