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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

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ClinicalTrials.gov Identifier: NCT04895410
Recruitment Status : Terminated (Strategic considerations)
First Posted : May 20, 2021
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date July 8, 2022
Actual Study Start Date  ICMJE January 17, 2022
Actual Primary Completion Date June 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2021)
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) [ Time Frame: Up to 28 days after study drug administration ]
DLT events as described in the protocol will be assessed.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: Lemzoparlimab
    Intravenous (IV) infusion
    Other Name: TJ011133
  • Drug: Dexamethasone
    Oral tablet or IV infusion/injection
  • Drug: Carfilzomib
    IV infusion
  • Drug: Pomalidomide
    Oral capsule
  • Biological: Daratumumab
    Subcutaneous (SC) injection
Study Arms  ICMJE
  • Experimental: Dose Escalation: Lemzoparlimab
    Participants will receive lemzoparlimab in 28 day cycles.
    Intervention: Biological: Lemzoparlimab
  • Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
    Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Drug: Pomalidomide
  • Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
    Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Drug: Carfilzomib
  • Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
    Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Biological: Daratumumab
  • Experimental: Dose Expansion: Lemzoparlimab
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
    Intervention: Biological: Lemzoparlimab
  • Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
  • Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Drug: Pomalidomide
  • Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Drug: Carfilzomib
  • Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
    Interventions:
    • Biological: Lemzoparlimab
    • Drug: Dexamethasone
    • Biological: Daratumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 6, 2022)
8
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2021)
163
Actual Study Completion Date  ICMJE June 24, 2022
Actual Primary Completion Date June 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Germany,   Israel,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04895410
Other Study ID Numbers  ICMJE M20-917
2021-001067-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP