At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Surzetoclax (drug), Daratumumab (drug), Dexamethasone (drug), Pomalidomide (drug)
- How long the study runs
- Study runs about 65 months (dates as stated)
- About the drug or intervention
- Surzetoclax — drug: Oral · Daratumumab — drug: Subcutaneous (SC) Injection · Dexamethasone — drug: Oral · Pomalidomide — drug: Oral · Etentamig — drug: Intravenous Infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 325
- Started
- 2025-07-23
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase1/Phase2 - 325 participants
- • Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Manchester - The Christie NHS Foundation Trust - Christie Hospital /ID# 276276
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. Surzetoclax is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 sites worldwide. In Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ measurable disease per central laboratory with at least 1 of the following assessed within 28 days
What the study is looking for
- ✓Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG)...
- ✓All participants must have cancer that can be measured on scans per central laboratory with at least 1 of the following assessed...
- ✓Serum M-protein \>= 0.5 g/dL (\>= 5g/L); OR
- ✓Urine M-protein \>= 200 mg/24 hours; OR
- ✓For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) \>= 10 mg/dL (100...
Who cannot take part
- ✗Major surgery within 4 weeks of study treatment or planned during study participation.
- ✗Recent infection requiring systemic treatment that was completed \<= 14 days before first dose of study treatment...
See the full criteria
Where Is This Study? (1 UK site)
The Christie NHS Foundation Trust - Christie Hospital /ID# 276276
Manchester M20 4BX, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
Sponsor contactCONTACT