[M22-947] Relapsed or Refractory Multiple Myeloma: Dose Escalation and Expansion of ABBV-383 in Combination with Anti-Cancer Regimens

JRCT ID: jRCT2021220022

Registered date:16/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 10/11/2022
• Target sample size: 270
• Countries of recruitment: US,Japan,Australia,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-day cycles.

Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.

Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.

Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.

Experimental: Arm D (ABBV-383 with Nirogacestat)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicities (DLT)

Secondary Outcome

- Overall Response Rate (ORR)
- Progression-Free Survival (PFS)
- Duration of Response (DOR)
- Time-to-Progression (TTP)
- Percentage of Participants with Minimal Residual Disease Negativity (MRD)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Must have confirmed 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.
- Must have measurable disease as outlined in the protocol.
- Must be naive to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Has received prior MM treatment in Arms A, B, C, and D.

Exclude criteria

- Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
- Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
- Known central nervous system involvement Multiple Myeloma (MM).
- Has any of the following conditions:
-- Nonsecretory MM.
-- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 x 10^9L circulating plasma cells by standard differential.
-- Waldenstrom's macroglobulinemia.
-- Light chain amyloidosis.
-- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
-- Major surgery within 4 weeks prior to first dose or planned study participation.
-- Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
-- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
-- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
- Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary ID(s): NCT05259839