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Monoclonal Antibodies
ABBV-383 for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be naïve to treatment with ABBV-383
Eastern Cooperative Oncology Group (ECOG) performance of <= 2
Must not have
Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test the safety and effectiveness of a new drug, ABBV-383, for treating patients with relapsed or refractory multiple myeloma, a type of blood cancer that
Who is the study for?
This trial is for adults with multiple myeloma that has returned or hasn't improved after treatment. Participants must have tried at least one prior therapy and be new to ABBV-383, with a decent ability to perform daily activities (ECOG <=2).
What is being tested?
The study tests the safety and how the body processes ABBV-383, given as an injection under the skin (SC) or into a vein (IV). It's divided into three parts: two dosage levels in Arm A (both SC and IV), and selected dose from Arm A in Arm B.
What are the potential side effects?
Specific side effects of ABBV-383 are not listed but may include typical reactions to cancer drugs like nausea, fatigue, potential infusion-related reactions for IV administration, and local site reactions for SC injections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never been treated with ABBV-383.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have multiple myeloma and have been treated with 3-5 different therapies including specific drug types.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received BCMAxCD3 bispecific antibody treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
Maximum Observed Concentration (Cmax) of ABBV-383
Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
+3 moreSecondary study objectives
Duration of Response (DoR)
Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)
Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: ABBV-383 ExpansionExperimental Treatment1 Intervention
Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.
Group II: ABBV-383 Dose BExperimental Treatment2 Interventions
Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.
Group III: ABBV-383 Dose AExperimental Treatment2 Interventions
Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
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Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,524 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,010 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,309 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,106 Patients Enrolled for Multiple Myeloma