Multiple Myeloma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04895410

Recruitment Status:

Terminated

Sponsor:

AbbVie

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There are 59 Locations for this study

See Locations Near You

University of Arizona Cancer Center - Tucson /ID# 229696
Tucson Arizona, 85724, United States
Yale University /ID# 230438
New Haven Connecticut, 06510, United States
Sylvester Comprehensive Cancer Center /ID# 228817
Miami Florida, 33136, United States
Moffitt Cancer Center /ID# 229939
Tampa Florida, 33612, United States
University of Kentucky Markey Cancer Center /ID# 229506
Lexington Kentucky, 40536, United States
Norton Cancer Institute - St Matthews /ID# 229319
Louisville Kentucky, 40207, United States
Tulane Cancer Center Clinic /ID# 229832
New Orleans Louisiana, 70112, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
Ann Arbor Michigan, 48109, United States
Henry Ford Health System /ID# 230341
Detroit Michigan, 48202, United States
Rutgers Cancer Institute of New Jersey /ID# 230174
New Brunswick New Jersey, 08901, United States
Columbia University Medical Center /ID# 229971
New York New York, 10032, United States
Duke University Hospital /ID# 229564
Durham North Carolina, 27710, United States
Wake Forest Baptist Health /ID# 229996
Winston-Salem North Carolina, 27157, United States
Perelman Center for Advanced Medicine - /ID# 228693
Philadelphia Pennsylvania, 19104, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473
Dallas Texas, 75246, United States
University of Texas Southwestern Medical Center /ID# 228830
Dallas Texas, 75390, United States
University of Virginia /ID# 229396
Charlottesville Virginia, 22908, United States
Concord Hospital /ID# 229351
Concord New South Wales, 2139, Australia
Princess Alexandra Hospital /ID# 229343
Woolloongabba Queensland, 4102, Australia
The Queen Elizabeth Hospital /ID# 229345
Woodville South South Australia, 5011, Australia
Royal Hobart Hospital /ID# 229348
Hobart Tasmania, 7000, Australia
Box Hill Hospital /ID# 240762
Box Hill Victoria, 3128, Australia
St Vincent's Hospital Melbourne /ID# 229349
Fitzroy Melbourne Victoria, 3065, Australia
Austin Health /ID# 229352
Heidelberg Victoria, 3084, Australia
Alfred Health /ID# 229347
Melbourne Victoria, 3004, Australia
HCL - Hôpital Lyon Sud /ID# 229834
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
CHU de Nantes, Hotel Dieu -HME /ID# 228559
Nantes Pays-de-la-Loire, 44000, France
CHU Poitiers - La milétrie /ID# 229833
Poitiers Poitou-Charentes, 86000, France
Hopital Henri Mondor /ID# 228562
Creteil , 94000, France
Universitaetsklinik Heidelberg /ID# 229145
Heidelberg Baden-Wuerttemberg, 69120, Germany
Robert-Bosch-Krankenhaus /ID# 230290
Stuttgart Baden-Wuerttemberg, 70736, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291
Berlin , 12203, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141
Hamburg , 20246, Germany
Asklepios Klinik Altona /ID# 229143
Hamburg , 22763, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007
Munich , 81675, Germany
The Chaim Sheba Medical Center /ID# 229483
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 229478
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Rambam Health Care Campus /ID# 229485
Haifa , 31096, Israel
Hadassah Medical Center-Hebrew University /ID# 229477
Jerusalem , 91120, Israel
Meir Medical Center /ID# 229480
Kfar Saba , 44281, Israel
Rabin Medical Center /ID# 229488
Petakh Tikva , 49414, Israel
Nagoya City University Hospital /ID# 241835
Nagoya shi Aichi, 467-8, Japan
National Cancer Center Hospital East /ID# 241834
Kashiwa-shi Chiba, 277-8, Japan
Kyushu University Hospital /ID# 241911
Fukuoka-shi Fukuoka, 812-8, Japan
Gunma University Hospital /ID# 241837
Maebashi-shi Gunma, 371-8, Japan
National Hospital Organization Mito Medical Center /ID# 244043
Higashi Ibaraki-gun Ibaraki, 311-3, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 241833
Kyoto-shi Kyoto, 602-8, Japan
Japanese Red Cross Medical Center /ID# 241836
Shibuya-ku Tokyo, 150-8, Japan
Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
Santiago de Compostela A Coruna, 15706, Spain
Hospital Unversitario Marques de Valdecilla /ID# 229354
Santander Cantabria, 39008, Spain
Hospital Parc de Salut del Mar /ID# 229371
Barcelona , 08003, Spain
Hospital Santa Creu i Sant Pau /ID# 229369
Barcelona , 08041, Spain
Hospital Universitario Reina Sofia /ID# 229388
Cordoba , 14004, Spain
Hospital Universitario 12 de Octubre /ID# 229355
Madrid , 28041, Spain
University Hospital Southampton NHS Foundation Trust /ID# 228332
Southampton Hampshire, SO16 , United Kingdom
Guy's and St Thomas' NHS Foundation Trust /ID# 228323
London London, City Of, SE1 9, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 228328
Oxford Oxfordshire, OX3 9, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 228333
Leeds , LS9 7, United Kingdom
The Christie Hospital /ID# 228330
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04895410

Recruitment Status:

Terminated

Sponsor:


AbbVie

How clear is this clinincal trial information?

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