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RecruitingLast updated: 26 February 2024

This phase I study is assessing how safe and effective a new targeted therapy (ABBV-383) is when given in addition to other anti-cancer treatments in adults with relapsed or refractory multiple myeloma.A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Clinical summary

Summary

Eligible participants will be allocated to one of four experimental arms.

In Experimental Arm A, participants will receive ABBV-383 (via intravenous [IV] infusion) in combination with dexamethasone (via oral tablet or IV infusion) and pomalidomide (via oral capsule).

In Experimental Arm B, participants will receive ABBV-383 (via IV infusion) in combination with lenalidomide (via oral capsule) and dexamethasone (via oral tablet or IV infusion).

In Experimental Arm C, participants will receive ABBV-383 (via IV infusion) in combination with Daratumumab (via subcutaneous injection) and dexamethasone (via oral tablet or IV infusion).

In Experimental Arm D, participants will receive ABBV-383 (via IV infusion) in combination with nirogacestat (via oral tablet).

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

TeneoOne Inc.

Scientific Title

A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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