A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

Study Purpose

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. 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. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 naïve 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:

- 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 × 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05259839
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	TeneoOne Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	TeneoOne Inc
Principal Investigator Affiliation	TeneoOne Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Germany, Italy, Japan, Poland, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsed/Refractory Multiple Myeloma

Arms & Interventions

Arms

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.

Interventions

Drug: - ABBV-383

Intravenous (IV) Infusion

Drug: - Dexamethasone

Oral; Tablet or IV Infusion

Drug: - Lenalidomide

Oral; Capsule

Drug: - Pomalidomide

Oral; Capsule

Drug: - Nirogacestat

Oral; Tablet

Drug: - Daratumumab

Subcutaneous Injection (SC)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences /ID# 243096

Little Rock, Arkansas, 72205

Site Contact

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