NCT06953960 A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
| NCT ID | NCT06953960 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AbbVie |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 325 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 325 participants in total. It began in 2025-07-23 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria. * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: * 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 mg/L), provided sFLC ratio is abnormal. * B-cell lymphoma (BCL)-2 inhibitor treatment naïve. * t(11;14) positive status and/or BCL2 high status. * Must have confirmed diagnosis of relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria. Exclusion Criteria: * 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 and/or uncontrolled active systemic infection.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT06953960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06953960 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06953960 currently recruiting?
Yes, NCT06953960 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT06953960 trial being conducted?
This trial is being conducted at Los Angeles, United States, New Haven, United States, Boston, United States, Ann Arbor, United States and 11 additional locations.
Who is sponsoring the NCT06953960 clinical trial?
NCT06953960 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 325 participants.