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A Phase 3, Multicenter, Randomized, Open Label Study of ABBV-383 vs Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2024-046
NCT ID
NCT06158841
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Cole, Craig
Objective:
Primary Objective:
The primary objective is to evaluate the efficacy, safety, and tolerability of ABBV-383 administered as monotherapy in adult subjects with RRMM who have received at least 2 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 mAb.
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
Serum M-protein >= 0.5 g/dL (>= 5 g/L).
Urine M-protein >= 200 mg/24 hours.
In participants without measurable serum or urine M protein, serum free light chain (FLC) >= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
Must be naïve to treatment with B-cell maturation antigen (BCMA)-targeted therapy.
Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion Criteria:
Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Multiple Myeloma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy, Immunotherapy
Drugs
ABBV-383; Bortezomib; Carfilzomib; Dexamethasone; Pomalidomide; Selinexor; elotuzumab
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