Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Condition(s) studied

Investigational drug(s) / intervention(s)

Subcutaneous (SC) Etentamig: SC Injection

Intravenous (IV) Etentamig: IV Infusion

Study summary

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.

Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world

In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events — Up to 2 cycles (56 days)
  Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
• Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events — Up to 2 cycles (56 days)
  ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
• Maximum Observed Concentration (Cmax) of ABBV-383 — Up to 32 weeks
  Cmax of ABBV-383.
• Time to Cmax (Tmax) of ABBV-383 — Up to 32 weeks
  Tmax of ABBV-383.
• Trough Concentration (Ctrough) of ABBV-383 — Up to 32 weeks
  Ctrough of ABBV-383.
• Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383 — Up to 24 weeks
  AUC of ABBV-383.

Trial sites (15)

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