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Compares treatment options for Relapsed/Refractory Multiple Myeloma
Official title A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT06508983
What this study is testing
What is SG301 Injection?
SG301 Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for relapsed/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
- The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Understand and voluntarily sign the informed consent form (ICF).
- Males and females aged 18-75 years (inclusive)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
- Expected survival time of ≥3 months.
- people had a documented diagnosis of multiple myeloma with evidence of measurable disease.
You likely can't join if
- Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the...
- Bone independent extramedullary disease at screening.
- people who are primary refractory to a prior CD38 monoclonal antibody therapy.
- Previous exposure to pomalidomide.
- Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is...
- Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of...
See the full eligibility criteria
- Understand and voluntarily sign the informed consent form (ICF).
- Males and females aged 18-75 years (inclusive)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
- Expected survival time of ≥3 months.
- people had a documented diagnosis of multiple myeloma with evidence of measurable disease.
- people had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
- people must have documented evidence of PD on or after the last regimen.
- Adequate function of vital organs
- Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after...
- Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
- Bone independent extramedullary disease at screening.
- people who are primary refractory to a prior CD38 monoclonal antibody therapy.
- Previous exposure to pomalidomide.
- Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;
- Active hepatitis B, or C.
- Known HIV infection.
- Known active tuberculosis or positive treponema pallidum antibodies.
- people with clinical significant organ dysfunction that does not meet the study needs.
- Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
- Known allergy to any component of the investigational medicinal product.
- Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Luoyang, Henan, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Suzhou, Jiangsu, 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.