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Monoclonal Antibodies
ABBV-383 Combo for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by TeneoOne Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have confirmed diagnosis of Relapsed/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) criteria
Eastern Cooperative Oncology Group (ECOG) performance of <= 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Study Summary
This trial is assessing the safety and toxicity of ABBV-383 in combination with other drugs for the treatment of relapsed or refractory multiple myeloma.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had previous treatments can join this trial. They must have a certain level of physical ability (ECOG <=2), measurable disease, and no prior BCMA-targeted therapy. Exclusions include recent major surgery, active infections or uncontrolled conditions like diabetes or hypertension, recent stem cell transplants, unresolved side effects from past cancer therapies, central nervous system involvement in MM, and certain other medical conditions.Check my eligibility
What is being tested?
The study is testing ABBV-383 combined with anti-cancer regimens (Pd/Rd/Dd/Niro) for safety and effect on disease activity in multiple myeloma patients. Participants are grouped to receive different combinations intravenously over 28-day cycles. The trial includes phases to find the best dose of ABBV-383 and confirm it through more participants at various global sites.See study design
What are the potential side effects?
Potential side effects may include reactions related to IV infusion such as discomfort or pain at the injection site, allergic reactions; blood disorders; fatigue; organ inflammation; increased risk of infection due to immune system suppression by chemotherapy drugs used alongside ABBV-383.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has returned or didn't respond to treatment, as confirmed by tests.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have previously received treatment for multiple myeloma in specific trial arms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate (ORR)
Percentage of Participants with Minimal Residual Disease Negativity (MRD)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Arm D (ABBV-383 with Nirogacestat)Experimental Treatment2 Interventions
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.
Group II: Arm C (ABBV-383 with Daratumumab and Dexamethasone)Experimental Treatment3 Interventions
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.
Group III: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)Experimental Treatment3 Interventions
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.
Group IV: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)Experimental Treatment3 Interventions
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
TeneoOne Inc.Lead Sponsor
3 Previous Clinical Trials
340 Total Patients Enrolled
3 Trials studying Multiple Myeloma
340 Patients Enrolled for Multiple Myeloma
TeneoOne IncStudy DirectorTeneoOne Inc.
2 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Multiple Myeloma
340 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe nerve pain or damage in my hands or feet.My multiple myeloma has spread to my brain or spinal cord.You have a current infection of hepatitis B, hepatitis C, or HIV.I have no ongoing major side effects from previous cancer treatments.My multiple myeloma does not produce detectable levels of M protein.I have been diagnosed with light chain amyloidosis.I have a high number of plasma cells in my blood, indicating active plasma cell leukemia.My diabetes or blood pressure has been uncontrolled in the last 2 weeks.My multiple myeloma has returned or didn't respond to treatment, as confirmed by tests.I can take care of myself but might not be able to do heavy physical work.I have not had any serious infections needing treatment in the last 14 days.You must have a specific amount of disease that can be measured as described in the study plan.I have previously received treatment for multiple myeloma in specific trial arms.I have been diagnosed with POEMS syndrome.I have not had major surgery in the last 4 weeks.I had a stem cell transplant from my own cells within the last 12 weeks or from a donor within the last year.I have been diagnosed with Waldenstrom's macroglobulinemia.I have never been treated with ABBV-383 or any BCMA-targeted therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
- Group 2: Arm C (ABBV-383 with Daratumumab and Dexamethasone)
- Group 3: Arm D (ABBV-383 with Nirogacestat)
- Group 4: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are involved in this experimental protocol?
"To meet the requirements of this clinical trial, 270 qualified participants must be recruited from two medical centres in Miami and Montana. More specifically, Sylvester Comprehensive Cancer Center (ID# 243673) located in Florida and Bozeman Health Cancer Center (ID# 243830), found in Montana."
Answered by AI
What is the overarching goal of this clinical exploration?
"The primary objective of this research trial, conducted over 3 years, is to evaluate the prevalence of dose limiting toxicities (DLT) associated with ABBV-383. Secondary outcomes include assessment of minimal residual disease negativity (MRD), overall response rate (ORR), and progression-free survival (PFS)."
Answered by AI
Are there any Canadian locations that have commenced this medical experiment?
"Presently, this medical trial has 16 active sites such as Sylvester Comprehensive Cancer Center/ID# 243673 in Miami, Bozeman Health Cancer Center /ID# 243830 in Bozeman and Levine Cancer Institute Atrium Health / ID #242851 in Charlotte. An additional 14 locations are also participating."
Answered by AI
Has ABBV-383 achieved regulatory endorsement from the FDA?
"As a Phase 1 trial, ABBV-383's safety profile has not been extensively tested yet and thus receives a score of 1."
Answered by AI
Is enrollment for this trial still open to participants?
"Evident from clinicaltrials.gov, this medical trial is presently inviting participants to engage in the study. This research was initially published on October 20th 2022 and had its last update on November 21st 2022."
Answered by AI
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