Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

Overview

The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult patients with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

SparkCures ID 1179
Trial Phase Phase 1
Enrollment 163 Patients
Treatments
Tags
Trial Sponsors
  • AbbVie
NCT Identifier

NCT04895410

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • 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.
    • Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
    • Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
  • Measurable disease per the protocol within 28 days prior to enrollment.
  • Arm A - Lemzoparlimab with or without Dexamethasone
    • For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
  • Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
    • For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
    • For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
  • Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
    • For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
    • For Expansion Phase- Participant must have received at least 1 prior line of therapy.
  • Arm D - Lemzoparlimab + Daratumumab-Dexamethasone -- For Both Escalation and Expansion Phase - Participant must: --- Have received at least 3 prior lines of therapy, as outlined in the protocol.

Exclusion Criteria:

  • Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
    • For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
  • Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
    • For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
  • Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
    • For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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