[M22-947] Relapsed or Refractory Multiple Myeloma: Dose Escalation and Expansion of ABBV-383 in Combination with Anti-Cancer Regimens
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2021220022
- Lead Sponsor
- Satomi Natsuko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 270
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities (DLT)
- Secondary Outcome Measures
Name Time Method - Overall Response Rate (ORR) <br>- Progression-Free Survival (PFS)<br>- Duration of Response (DOR)<br>- Time-to-Progression (TTP)<br>- Percentage of Participants with Minimal Residual Disease Negativity (MRD)