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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 163 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Comprehensive Cancer Center

Tucson, AZ

Not Yet Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Kentucky

UK Markey Cancer Center University of Kentucky

Lexington, KY

Not Yet Accepting

Norton Cancer Institute St. Matthews Campus

Louisville, KY

Open and Accepting

Louisiana

Tulane Cancer Center Tulane University School of Medicine

New Orleans, LA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Not Yet Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

New Jersey

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

New York

North Carolina

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

Winston-Salem, NC

Not Yet Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Not Yet Accepting

Pennsylvania

Penn Presbyterian Medical Center University of Pennsylvania

Philadelphia, PA

Not Yet Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Not Yet Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting
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