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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04895410
Other study ID # M20-917
Secondary ID 2021-001067-24
Status Terminated
Phase Phase 1
First received
Last updated
Start date January 17, 2022
Est. completion date June 24, 2022

Study information

Verified date August 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date June 24, 2022
Est. primary completion date June 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Lemzoparlimab
Intravenous (IV) infusion
Drug:
Dexamethasone
Oral tablet or IV infusion/injection
Carfilzomib
IV infusion
Pomalidomide
Oral capsule
Biological:
Daratumumab
Subcutaneous (SC) injection

Locations

Country Name City State
Australia Alfred Health /ID# 229347 Melbourne Victoria
Australia The Queen Elizabeth Hospital /ID# 229345 Woodville South South Australia
France Hopital Henri Mondor /ID# 228562 Creteil
France CHU de Nantes, Hotel Dieu -HME /ID# 228559 Nantes Pays-de-la-Loire
France HCL - Hôpital Lyon Sud /ID# 229834 Pierre Benite CEDEX Auvergne-Rhone-Alpes
France CHU Poitiers - La milétrie /ID# 229833 Poitiers Poitou-Charentes
Germany Asklepios Klinik Altona /ID# 229143 Hamburg
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 The Chaim Sheba Medical Center /ID# 229483 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 229478 Tel Aviv-Yafo Tel-Aviv
Japan University Hospital Kyoto Prefectural University of Medicine /ID# 241833 Kyoto-shi Kyoto
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 Hospital Unversitario Marques de Valdecilla /ID# 229354 Santander Cantabria
Spain Hospital Clínico Universitario de Santiago-CHUS /ID# 229356 Santiago de Compostela A Coruna
United States University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309 Ann Arbor Michigan
United States University of Virginia /ID# 229396 Charlottesville Virginia
United States Henry Ford Health System /ID# 230341 Detroit Michigan
United States Duke University Hospital /ID# 229564 Durham North Carolina
United States Norton Cancer Institute - St Matthews /ID# 229319 Louisville Kentucky
United States Sylvester Comprehensive Cancer Center /ID# 228817 Miami Florida
United States Rutgers Cancer Institute of New Jersey /ID# 230174 New Brunswick New Jersey
United States Tulane Cancer Center Clinic /ID# 229832 New Orleans Louisiana
United States Columbia University Medical Center /ID# 229971 New York New York
United States Perelman Center for Advanced Medicine - /ID# 228693 Philadelphia Pennsylvania
United States Moffitt Cancer Center /ID# 229939 Tampa Florida
United States Wake Forest Baptist Health /ID# 229996 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Japan,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better 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. Up to approximately 2 years
Secondary Progression Free Survival (PFS) 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. Up to approximately 2 years
Secondary Duration of Response (DOR) 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. Up to approximately 2 years
Secondary Time to Progression (TTP) 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. Up to approximately 2 years
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