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
- Conditions
- Multiple Myeloma
- Interventions
- Biological: LemzoparlimabBiological: Daratumumab
- Registration Number
- NCT04895410
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
-
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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation: Lemzoparlimab Lemzoparlimab Participants will receive lemzoparlimab in 28 day cycles. Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone Daratumumab Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone Daratumumab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles. Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone Carfilzomib Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone Dexamethasone Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone Pomalidomide Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone Dexamethasone Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles. Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone Dexamethasone Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Dexamethasone Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone Pomalidomide Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone Carfilzomib Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles. Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
- Primary Outcome Measures
Name Time Method 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) Up to 28 days after study drug administration DLT events as described in the protocol will be assessed.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better Up to approximately 2 years Best overall response is defined as achieving documented PR or better at two consecutive disease assessments during the study, according to International Myeloma Working Group (IMWG) 2016 criteria.
Progression Free Survival (PFS) Up to approximately 2 years PFS is defined as the time from the first dose of study drug to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Duration of Response (DOR) Up to approximately 2 years DOR is defined as the time from first documented response (PR or better) to the first documented PD or death due to MM, whichever occurs first.
Time to Progression (TTP) Up to approximately 2 years TTP is defined as the time from the first dose of study drug to the first documented PD or death due to MM, whichever occurs first.
Trial Locations
- Locations (32)
Moffitt Cancer Center /ID# 229939
🇺🇸Tampa, Florida, United States
Norton Cancer Institute - St Matthews /ID# 229319
🇺🇸Louisville, Kentucky, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
🇺🇸Ann Arbor, Michigan, United States
Rutgers Cancer Institute of New Jersey /ID# 230174
🇺🇸New Brunswick, New Jersey, United States
Columbia University Medical Center /ID# 229971
🇺🇸New York, New York, United States
Wake Forest Baptist Health /ID# 229996
🇺🇸Winston-Salem, North Carolina, United States
Perelman Center for Advanced Medicine - /ID# 228693
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia /ID# 229396
🇺🇸Charlottesville, Virginia, United States
The Queen Elizabeth Hospital /ID# 229345
🇦🇺Woodville South, South Australia, Australia
Alfred Health /ID# 229347
🇦🇺Melbourne, Victoria, Australia
HCL - Hôpital Lyon Sud /ID# 229834
🇫🇷Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CHU de Nantes, Hotel Dieu -HME /ID# 228559
🇫🇷Nantes, Pays-de-la-Loire, France
Hopital Henri Mondor /ID# 228562
🇫🇷Creteil, France
CHU Poitiers - La milétrie /ID# 229833
🇫🇷Poitiers, Poitou-Charentes, France
Asklepios Klinik Altona /ID# 229143
🇩🇪Hamburg, Germany
The Chaim Sheba Medical Center /ID# 229483
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 229478
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Rambam Health Care Campus /ID# 229485
🇮🇱Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 229477
🇮🇱Jerusalem, Israel
Meir Medical Center /ID# 229480
🇮🇱Kfar Saba, Israel
Rabin Medical Center /ID# 229488
🇮🇱Petakh Tikva, Israel
University Hospital Kyoto Prefectural University of Medicine /ID# 241833
🇯🇵Kyoto-shi, Kyoto, Japan
Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital Unversitario Marques de Valdecilla /ID# 229354
🇪🇸Santander, Cantabria, Spain
Hospital Parc de Salut del Mar /ID# 229371
🇪🇸Barcelona, Spain
Hospital Santa Creu i Sant Pau /ID# 229369
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia /ID# 229388
🇪🇸Cordoba, Spain
Hospital Universitario 12 de Octubre /ID# 229355
🇪🇸Madrid, Spain
Sylvester Comprehensive Cancer Center /ID# 228817
🇺🇸Miami, Florida, United States
Henry Ford Health System /ID# 230341
🇺🇸Detroit, Michigan, United States
Duke University Hospital /ID# 229564
🇺🇸Durham, North Carolina, United States
Tulane Cancer Center Clinic /ID# 229832
🇺🇸New Orleans, Louisiana, United States