A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-438: Intravenous (IV)

Study summary

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, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed/refractory (R/R) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed.

ABBV-438 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R/R MM will be enrolled in the study in approximately 24 sites worldwide.

Participants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months.

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.

Eligibility

Primary outcome measure(s)

• Number of Participants With Adverse Events (AE) — Up to Approximately 69.5 Months
  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters — Up to Approximately 69.5 Months
  Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.
• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters — Up to Approximately 69.5 Months
  Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
• Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) — Up to Approximately 69.5 Months
  A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.

Trial sites (11)

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