A Phase 3 study of ABBV-383 vs Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) (3L+ RRMM Monotherapy Study)

Phase 1

• Conditions: Relapsed or Refractory Multiple Myeloma (RRMM); MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506668-15-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

Adult individuals, male or female, =18 years old., Subject must be eligible to receive the Investigator's choice SAT based on approved prescribing information, previous MM treatment history, and institutional guidelines., Subjects must accept to be treated with one of the pre-specified Standard Available Therapies (SAT), based on Investigator's choice of local standard of care., Subjects must consent to a fresh pretreatment bone marrow tumor aspirate and biopsy or has adequate archival bone marrow tumor tissue that was collected within 12 weeks prior to first dose and without intervening treatment., Eastern Cooperative Oncology Group (ECOG) performance status of =2., Subjects must meet the laboratory parameters, as specified in the study protocol, within 2 weeks prior of the first dose of study drug., Subjects must has a diagnosis of relapsed and/or refractory MM during or after the subject's last treatment, Subjects must have measurable disease within 28 days prior to randomization, defined as at lease 1 of the following: Serum monoclonal paraprotein (M-protein) =0.5 g/dL (=5 g/L); Urine M-protein =200 mg/24 hours; In subjects without measurable serum or urine M-protein, serum FLC =100 mg/L (10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio., Subject must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb., Subject with known HIV will be permitted provided that the subject has an undetectable HIV viral load by standard clinical assays on antiretroviral medication (HAART) and is able to tolerate study treatment per Investigator's judgement.

Exclusion Criteria

History of significant cardiovascular or pericardial disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, Class =3 New York Heart Association congestive heart failure., Subjects have evidence of active hepatitis C infection based on screening blood testing., Subject has any of the following conditions: - Non-secretory MM; - Active plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 109 /L circulating plasma cells by standard differential; - Waldenstrom's macroglobulinemia; - Light chain amyloidosis; - POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes); - Major surgery within 4 weeks prior to first dose or planned study participation; or Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal, or antiviral)., SAT-Specific Exclusion Criteria: Subject is not eligible if they have received carfilzomib, elotuzumab, and selinexor., SAT-Specific Exclusion Criteria: Subject is not eligible to receive Kd if subject has received prior carfilzomib therapy., SAT-Specific Exclusion Criteria: Subject is not eligible to received SVd if: - Subject has received prior selinexor therapy; - Prior PI treatment is allowed provided that subject achieved =PR and > 6 months has elapsed since last PI, with no history of discontinuation due to =Grade 3 toxicity., SAT-Specific Exclusion Criteria: Subject is not eligible to receive EloPd if subject has received prior elotuzumab or pomalidomide therapy., Subject have a known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV- 2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart., History of 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 subject's participation in the study., History of any malignancy within the past 3 years with the following exceptions: - Adequately treated in situ carcinoma of the cervix uteri or the breast; - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; - Prostate cancer Gleason Grade 6 or lower AND with stable PSA levels on or off treatment; - Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study., Subjects have received BCMA-targeted therapy, Subjects have known central nervous system involvement of MM., History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months., Known allergies, hypersensitivities, or intolerance to constituents of the study drug (and its excipients) or derivatives., Subjects have evidence of active hepatitis B (HbsAg positive) infection based on screening blood testing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified