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NCT Number: NCT06223516

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universitaetsklinikum Frankfurt /ID# 260442, Frankfurt am Main, Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
  • Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.
  • Must be naïve to treatment with ABBV-383.

Exclusion criteria

  • Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Treatment and study plan

Subcutaneous (SC) Etentamig

Drug

SC Injection

Intravenous (IV) Etentamig

Drug

IV Infusion

Primary outcomes

  1. Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events

    Time frame: 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.

  2. Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events

    Time frame: Up to 2 cycles (56 days)

    ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.

  3. Maximum Observed Concentration (Cmax) of ABBV-383

    Time frame: Up to 32 weeks

    Cmax of ABBV-383.

  4. Time to Cmax (Tmax) of ABBV-383

    Time frame: Up to 32 weeks

    Tmax of ABBV-383.

  5. Trough Concentration (Ctrough) of ABBV-383

    Time frame: Up to 32 weeks

    Ctrough of ABBV-383.

  6. Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383

    Time frame: Up to 24 weeks

    AUC of ABBV-383.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 24 months

    The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by international myeloma working group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy.

  2. Percentage of Participants Achieving Stringent Complete Response (sCR),

    Time frame: Up to 24 months

    sCR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, normal free light chain (FLC) ratio, and Absence of clonal cells in bone marrow by immunohistochemistry.

  3. Percentage of Participants Achieving Complete Response (CR)

    Time frame: Up to 24 months

    CR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio.

  4. Percentage of Participants Achieving Very Good Partial Response (VGPR)

    Time frame: Up to 24 months

    VGPR is defined as participants achieving serum and urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein plus urine, and for participants in whom the only measurable disease is by serum FLC levels, >= 90% decrease in the difference between involved and uninvolved FLC levels.

  5. Percentage of Participants Achieving Partial Response (PR)

    Time frame: Up to 24 months

    PR is defined as participants achieving >= 50% reduction of serum M-protein, reduction in 24-hour urinary M-protein by >= 90% as noted in the protocol, >= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.

  6. Duration of Response (DoR)

    Time frame: Up to 24 months

    DoR will be defined as the time from the date of first response [partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR)] to the earliest occurrence of progressive disease, or death, whatever occurs first.

  7. Progression Free Survival (PFS)

    Time frame: Up to 24 months

    PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) per international myeloma working group (IMWG) criteria, or death, whichever occurs first.

  8. Time to Response (TTR)

    Time frame: Up to 24 months

    TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria.

  9. Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)

    Time frame: Up to 27 months

    Incidence and concentration of ADAs.

  10. Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)

    Time frame: Up to 27 months

    Incidence and concentration of NAbs.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Phase 1b, Open-label Study of Etentamig (ABBV-383) Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 25, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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