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Monoclonal Antibodies
Lemzoparlimab for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
Study Summary
Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma
Eligible Conditions
- Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Refractory anemias
Secondary outcome measures
Duration of Response (DOR)
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Progression Free Survival (PFS)
+1 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Dose Expansion: Lemzoparlimab + Pomalidomide + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Group II: Dose Expansion: Lemzoparlimab + DexamethasoneExperimental Treatment2 Interventions
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Group III: Dose Expansion: Lemzoparlimab + Daratamumab + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Group IV: Dose Expansion: Lemzoparlimab + Carfilzomib + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Group V: Dose Expansion: LemzoparlimabExperimental Treatment1 Intervention
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
Group VI: Dose Escalation: Lemzoparlimab + Pomalidomide + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
Group VII: Dose Escalation: Lemzoparlimab + Daratumumab + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
Group VIII: Dose Escalation: Lemzoparlimab + Carfilzomib + DexamethasoneExperimental Treatment3 Interventions
Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
Group IX: Dose Escalation: LemzoparlimabExperimental Treatment1 Intervention
Participants will receive lemzoparlimab in 28 day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1440
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
947 Previous Clinical Trials
496,584 Total Patients Enrolled
34 Trials studying Multiple Myeloma
5,383 Patients Enrolled for Multiple Myeloma
ABBVIE INC.Study DirectorAbbVie
388 Previous Clinical Trials
141,265 Total Patients Enrolled
14 Trials studying Multiple Myeloma
2,479 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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