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

Multiple Myeloma Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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