Study Stopped
Strategic considerations
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
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
2 other identifiers
interventional
8
7 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-myeloma
Started Jan 2022
Shorter than P25 for phase_1 multiple-myeloma
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
January 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2022
CompletedMarch 6, 2023
August 1, 2022
5 months
May 19, 2021
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicities (DLTs) of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM)
DLT events as described in the protocol will be assessed.
Up to 28 days after study drug administration
Secondary Outcomes (4)
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Up to approximately 2 years
Progression Free Survival (PFS)
Up to approximately 2 years
Duration of Response (DOR)
Up to approximately 2 years
Time to Progression (TTP)
Up to approximately 2 years
Study Arms (9)
Dose Escalation: Lemzoparlimab
EXPERIMENTALParticipants will receive lemzoparlimab in 28 day cycles.
Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
Dose Expansion: Lemzoparlimab
EXPERIMENTALParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
Dose Expansion: Lemzoparlimab + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
EXPERIMENTALParticipants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Interventions
Intravenous (IV) infusion
Oral tablet or IV infusion/injection
IV infusion
Oral capsule
Subcutaneous (SC) injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (32)
Sylvester Comprehensive Cancer Center /ID# 228817
Miami, Florida, 33136-1002, United States
Moffitt Cancer Center /ID# 229939
Tampa, Florida, 33612-9416, 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, 10032-3729, United States
Duke University Hospital /ID# 229564
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health /ID# 229996
Winston-Salem, North Carolina, 27157-0001, United States
Perelman Center for Advanced Medicine - /ID# 228693
Philadelphia, Pennsylvania, 19104-5127, United States
University of Virginia /ID# 229396
Charlottesville, Virginia, 22908, United States
The Queen Elizabeth Hospital /ID# 229345
Woodville South, South Australia, 5011, Australia
Alfred Health /ID# 229347
Melbourne, Victoria, 3004, Australia
HCL - Hôpital Lyon Sud /ID# 229834
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
CHU de Nantes, Hotel Dieu -HME /ID# 228559
Nantes, Pays de la Loire Region, 44000, France
CHU Poitiers - La milétrie /ID# 229833
Poitiers, Poitou-Charentes, 86000, France
Hopital Henri Mondor /ID# 228562
Créteil, 94000, France
Asklepios Klinik Altona /ID# 229143
Hamburg, 22763, Germany
The Chaim Sheba Medical Center /ID# 229483
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 229478
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 229485
Haifa, 3109601, Israel
Hadassah Medical Center-Hebrew University /ID# 229477
Jerusalem, 91120, Israel
Meir Medical Center /ID# 229480
Kfar Saba, 4428164, Israel
Rabin Medical Center /ID# 229488
Petah Tikva, 4941492, Israel
University Hospital Kyoto Prefectural University of Medicine /ID# 241833
Kyoto, Kyoto, 602-8566, 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
Córdoba, 14004, Spain
Hospital Universitario 12 de Octubre /ID# 229355
Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 20, 2021
Study Start
January 17, 2022
Primary Completion
June 24, 2022
Study Completion
June 24, 2022
Last Updated
March 6, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share