Clinical trial NCT04895410: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Lemzoparlimab
ABBV-IMAB-TJC4
Relapsed or refractory multiple myeloma (R/R MM)
Cancer
TJ011133
Multiple Myeloma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: Up to 28 days after study drug administration
Secondary outcomes:
measure: Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
timeFrame: Up to approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Time to Progression (TTP)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center /ID# 228817
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center /ID# 229939
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute - St Matthews /ID# 229319
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Cancer Center Clinic /ID# 229832
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 230341
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey /ID# 230174
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center /ID# 229971
state: New York
city: Durham
country: United States
facility: Duke University Hospital /ID# 229564
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health /ID# 229996
state: North Carolina
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine - /ID# 228693
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia /ID# 229396
state: Virginia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital /ID# 229345
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Health /ID# 229347
state: Victoria
city: Pierre Benite CEDEX
country: France
facility: HCL - Hôpital Lyon Sud /ID# 229834
state: Auvergne-Rhone-Alpes
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 228559
state: Pays-de-la-Loire
city: Poitiers
country: France
facility: CHU Poitiers - La milétrie /ID# 229833
state: Poitou-Charentes
city: Creteil
country: France
facility: Hopital Henri Mondor /ID# 228562
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona /ID# 229143
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 229483
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 229478
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 229485
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 229477
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 229480
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 229488
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 241833
state: Kyoto
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
state: A Coruna
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 229354
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 229371
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 229369
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 229388
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 229355
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: