Multiple Myeloma
Conditions
Interventions
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 Pom
Sponsors
Satomi Natsuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Countries
Australia, Germany, Italy, Japan, Poland, Spain, US
Contacts
Public ContactContact for Patients and HCP
AbbVie. G.K.
Outcome results
None listed