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New treatment option for Multiple Myeloma
Official title 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)
ClinicalTrials.gov ID: NCT06953960
What this study is testing
What is ABBV-453?
ABBV-453 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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
- 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.
- Phase 2: a mid-size study of how well it works
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
- 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.
You likely can't join if
- Major surgery within 4 weeks of study treatment or planned during study participation.
- Active infections: no recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or...
- Recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or uncontrolled active systemic...
See the full eligibility 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.
- Substudy 1 Dose Escalation Cohorts and Substudy 2: \-- Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment...
- Substudy 1 Dose Expansion Cohorts:
- Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.
- Major surgery within 4 weeks of study treatment or planned during study participation.
- Active infections: no recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or uncontrolled systemic infection.
- Recent infection requiring systemic treatment that was completed \<= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Tacoma, Washington, United States
- Liverpool, New South Wales, Australia
- Waratah, New South Wales, Australia
- Fitzroy, Victoria, Australia
- Richmond, Victoria, Australia
- Ghent, Oost-Vlaanderen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Liège, Belgium
- Montpellier, Herault, France
- Poitiers, New Aquitaine, France
+ 27 more site(s).
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 Los Angeles, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Chapel Hill, North Carolina, United States and 41 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.