Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria
Eastern Cooperative Oncology Group (ECOG) performance status <= 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months
Awards & highlights
Study Summary
This trial is designed to study the safety and tolerability of ABBV-453 in patients with R/R MM. The trial will enroll approximately 21 participants who will receive ABBV-453 orally in 28-day cycles.
Who is the study for?
Adults with relapsed or refractory Multiple Myeloma who have measurable disease, meet specific lab criteria, and are in good enough health to participate. Those in earlier parts of the trial must have tried all other beneficial treatments without success. Later parts require having had 1-3 prior therapies but no previous treatment with certain inhibitors.Check my eligibility
What is being tested?
The safety and effectiveness of ABBV-453 tablets for Multiple Myeloma are being tested. Participants will receive different combinations of ABBV-453 with dexamethasone, daratumumab, and lenalidomide across various groups to find the best dose and assess changes in their condition.See study design
What are the potential side effects?
Potential side effects include those common to cancer medications such as fatigue, nausea, blood count changes, potential heart issues (due to ECG exclusions), and possibly unique effects from ABBV-453 which are being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma according to IMWG standards.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My multiple myeloma has not responded to or I cannot tolerate standard treatments including PIs, IMIDs, and anti-CD38.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) per International Myeloma Working Group (IMWG) Criteria
Secondary outcome measures
Neoplasm, Residual
Duration of Response (DOR)
Overall Survival (OS)
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 2: Arm 3Experimental Treatment4 Interventions
Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles.
Group II: Part 2: Arm 2Experimental Treatment3 Interventions
Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles.
Group III: Part 2: Arm 1Experimental Treatment2 Interventions
Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles.
Group IV: Part 1: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined.
Group V: Japan CohortExperimental Treatment1 Intervention
Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 2
~1070
Daratumumab
2014
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
971 Previous Clinical Trials
504,768 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,031 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
406 Previous Clinical Trials
148,657 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,127 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a disease that can be measured according to the study's guidelines.I have been diagnosed with multiple myeloma according to IMWG standards.My cancer has a specific genetic feature (t(11;14) positive or BCL2high).I have been treated with venetoclax or a BCL-2 inhibitor before.I have been treated with venetoclax or a BCL-2 inhibitor before.Your lab test results need to meet the requirements in the study's plan.I've had 1-3 treatments before, including a proteasome inhibitor or an immunomodulatory drug.You have important abnormalities in your heart's electrical activity, as described in the study guidelines.You are expected to live for at least 12 more weeks.I am fully active and can carry on all pre-disease activities without restriction.I have previously been treated with daratumumab or another anti-CD38 therapy.My multiple myeloma has not responded to or I cannot tolerate standard treatments including PIs, IMIDs, and anti-CD38.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Arm 2
- Group 2: Part 2: Arm 1
- Group 3: Part 2: Arm 3
- Group 4: Part 1: Monotherapy Dose Escalation
- Group 5: Japan Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger