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

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Carfilzomib; Biological: Lemzoparlimab; Drug: Dexamethasone; Drug: Pomalidomide; Biological: Daratumumab

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 229345
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health /ID# 229347
• France
  • Creteil, France, 94000
    • Hopital Henri Mondor /ID# 228562
  • Auvergne-Rhone-Alpes
    • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
      • HCL - Hôpital Lyon Sud /ID# 229834
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 228559
  • Poitou-Charentes
    • Poitiers, Poitou-Charentes, France, 86000
      • CHU Poitiers - La milétrie /ID# 229833
• Germany
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona /ID# 229143
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 229485
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center-Hebrew University /ID# 229477
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 229480
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 229488
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 229483
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 229478
• Japan
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine /ID# 241833
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 229371
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 229369
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia /ID# 229388
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 229355
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Unversitario Marques de Valdecilla /ID# 229354
• United States
  • Florida
    • Miami, Florida, United States, 33136-1002
      • Sylvester Comprehensive Cancer Center /ID# 228817
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 229939
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute - St Matthews /ID# 229319
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center Clinic /ID# 229832
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 230341
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey /ID# 230174
  • New York
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 229971
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital /ID# 229564
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Health /ID# 229996
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5127
      • Perelman Center for Advanced Medicine - /ID# 228693
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia /ID# 229396

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation: Lemzoparlimab; Participants will receive lemzoparlimab in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133
Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone; Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection; Drug: Pomalidomide; Oral capsule
Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone; Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.	Drug: Carfilzomib; IV infusion; Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection
Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone; Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection; Biological: Daratumumab; Subcutaneous (SC) injection
Experimental: Dose Expansion: Lemzoparlimab; Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133
Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone; Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection
Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone; Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection; Drug: Pomalidomide; Oral capsule
Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone; Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.	Drug: Carfilzomib; IV infusion; Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection
Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone; Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.	Biological: Lemzoparlimab; Intravenous (IV) infusion; Other Names: TJ011133; Drug: Dexamethasone; Oral tablet or IV infusion/injection; Biological: Daratumumab; Subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Multiple Myeloma; Lemzoparlimab; TJ011133; ABBV-IMAB-TJC4; Relapsed or refractory multiple myeloma (R/R MM)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Pomalidomide; Daratumumab
• Other Study ID Numbers: M20-917; 2021-001067-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes