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Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab (TJ011133) With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04895410
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
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 (TJ01133) is and how lemzoparlimab (TJ01133) 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 (TJ01133) 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 (TJ011133) 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 (TJ011133), 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 (TJ011133) 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 (TJ011133) (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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Lemzoparlimab Drug: Dexamethasone Drug: Carfilzomib Drug: Pomalidomide Biological: Daratumumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab (TJ011133) With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : August 10, 2025
Estimated Study Completion Date : August 10, 2025


Arm Intervention/treatment
Experimental: Dose Escalation: Lemzoparlimab (TJ01133)
Participants will receive lemzoparlimab (TJ01133) in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) + pomalidomide + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Drug: Pomalidomide
Oral capsule

Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) + carfilzomib + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Drug: Carfilzomib
IV infusion

Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) + daratumumab + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Biological: Daratumumab
Subcutaneous (SC) injection

Experimental: Dose Expansion: Lemzoparlimab
Participants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Drug: Pomalidomide
Oral capsule

Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Drug: Carfilzomib
IV infusion

Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
Participants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Name: TJ011133

Drug: Dexamethasone
Oral tablet or IV infusion/injection

Biological: Daratumumab
Subcutaneous (SC) injection




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM) [ Time Frame: Up to 28 days after study drug administration ]
    DLT events as described in the protocol will be assessed.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better [ Time Frame: 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.

  2. Progression Free Survival (PFS) [ Time Frame: 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.

  3. Duration of Response (DOR) [ Time Frame: 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.

  4. Time to Progression (TTP) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 within 28 days prior to enrollment.
  • Arm A - Lemzoparlimab (TJ011133) with or without Dexamethasone

    • For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment including standard of care (SOC).
  • Arm B - Lemzoparlimab (TJ011133) + Pomalidomide-Dexamethasone

    • For Escalation Phase - Participant must have received at least 2 prior lines of therapy, including lenalidomide and a Proteasome inhibitor (PI).
    • For Expansion Phase - Participant must have received at least 1 prior line of therapy, including lenalidomide and a Proteasome inhibitor (PI).
  • Arm C - Lemzoparlimab (TJ011133) + Carfilzomib-Dexamethasone

    • For Both Escalation and Expansion Phase - Participant must have received at least 1 prior line of therapy.
  • Arm D - Lemzoparlimab (TJ011133) + Daratumumab-Dexamethasone

    • For Escalation Phase: Participant must have received at least 3 prior lines of therapy including a PI and an Immunomodulatory imide drug (IMiD).
    • For Expansion Phase: Participant must have received at least 1 prior line of therapy including a PI and an IMiD.

Exclusion Criteria:

  • Arm B - Lemzoparlimab (TJ011133) + Pomalidomide-Dexamethasone

    • For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
  • Arm C - Lemzoparlimab (TJ011133) + Carfilzomib-Dexamethasone

    • For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
  • Arm D - Lemzoparlimab (TJ011133) + Daratumumab-Dexamethasone

    • For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895410


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 49 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04895410    
Other Study ID Numbers: M20-917
2021-001067-24 ( EudraCT Number )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbbVie:
Lemzoparlimab
ABBV-IMAB-TJC4
Relapsed or refractory multiple myeloma (R/R MM)
Cancer
TJ011133
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Pomalidomide
Daratumumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors