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New treatment option for Relapsed or Refractory Multiple Myeloma
Official title Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06375044
What this study is testing
What is SIM0500?
SIM0500 is an investigational medicine, being studied as a potential treatment for relapsed or refractory multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary participation and signature of informed consent form.
- ≥18 years of age.
- Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic...
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
You likely can't join if
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral...
- 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...
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not...
- Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or...
See the full eligibility criteria
- Voluntary participation and signature of informed consent form.
- ≥18 years of age.
- 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.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Adequate hematologic, hepatic, and renal function.
- Toxicities from previous anticancer therapies should have resolved to baseline levels 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 ≥ 2,000 international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective...
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- 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...
- 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.
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Participants with known active infection within 14 days prior to the first SIM0500.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Tianjin, Tianjin Municipality, China
- Hanzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; New York, New York, United States; Beijing, Beijing Municipality, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.