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NCT04895410: Phase 1 -IV Lemzoparlimab +/- Oral/IV Dex plus Oral/IV/SC Anti-Myeloma Regimens

Updated: May 25

NCT04895410: 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

Lemzoparlimab

Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants 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.

Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.


Sponsor

AbbVie

 

ClinicalTrials.gov Identifier: NCT04895410


Official Title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

First Posted : May 20, 2021


Click here for details on ClinicalTrials.gov

 

Biological: Lemzoparlimab

anti-CD47 monoclonal antibody TJC4

TJ 011133

TJC4

 

Drug: Dexamethasone

Drug: Carfilzomib

Drug: Pomalidomide

Biological: Daratumumab

 

* Carfilzomib (Kyprolis)

* Dexamethasone (Decadron)

* Daratumumab (Darzalex)

* Pomalidomide (Pomalyst)

 

Multiple locations

International study

 

- Connecticut: Yale University New Haven

- Florida: Moffitt Cancer Center Tampa

- Florida: Sylvester Comprehensive Cancer Center - University of Miami

- Massachusetts: Massachusetts General Hospital Boston

- New Jersey: Rutgers Cancer Institute of New Jersey New Brunswick

- New York: Columbia University Medical Center New York

- North Carolina: Wake Forest Baptist Health Winston-Salem

 

Locations

United States, Arizona

United States, Connecticut

United States, Florida

United States, Kentucky

United States, Louisiana

United States, Michigan

United States, New Jersey

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, Texas

United States, Virginia

Australia, New South Wales

Australia, Queensland

Australia, South Australia

Australia, Tasmania

Australia, Victoria

Europe

United Kingdom

France

Germany

Spain

Asia

Israel

Japan






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