[M22-574] Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

JRCT ID: jRCT2071240020

Registered date:10/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 10/06/2024
• Target sample size: 380
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czech,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,South Africa,Japan,Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkiye,Japan,UK,Japan,US,Japan
• Study type: Interventional

Intervention(s)

Experimental: ABBV-383
Participants will receive ABBV-383 as a monotherapy.

Experimental: Standard Available Therapy (SAT)
Participants will receive SAT, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. SAT choices are carfilzomib + dexamethasone (Kd), elotuzumab +
pomalidomide + dexamethasone (EloPd), selinexor + bortezomib + dexamethasone (SVd).

Outcome(s)

Primary Outcome

Progression Free Survival (PFS)
Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)

Secondary Outcome

1. Objective Response Rate (ORR)
2. Overall Survival (OS)
3. Change in Rate of CR or Better (>=CR)
4. Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
5. Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)
6. Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
7. Time to Response (TTR)
8. Duration of Response (DOR)
9. Time-to-Progression (TTP)
10. Time to Next Anti-lymphoma Therapy (TTNT)
11. Number of Participants with Event-free Survival (EFS)
12. Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)
13. Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
14. Change from Baseline in Remaining Items in the EORTC QLQ-C30
15. Change from Baseline in Remaining Items in the EORTC QLQ-MY20
16. Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)
17. Change from Baseline in Patient Global Impression of Severity (PGIS)
18. Change from Baseline in Patient Global Impression of Change (PGIC)
19. Number of Participants with Skeletal-Related Event (SRE)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Confirmed diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment based on the Investigator's determination of the international myeloma working group (IMWG) (2016) response criteria.
- 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).
- 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 naive 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.

Exclude 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: renal, 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.
- Central nervous system involvement of MM.

Related Information

• Primary Sponsor: Natsuko Satomi
• Secondary ID(s): NCT06158841