Clinical Trials /

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

NCT04895410

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M20-917
  • SECONDARY ID: 2021-001067-24
  • NCT ID: NCT04895410

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
LemzoparlimabTJ011133Dose Escalation: Lemzoparlimab (TJ01133)
DexamethasoneDose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
CarfilzomibDose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
PomalidomideDose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
DaratumumabDose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation: Lemzoparlimab (TJ01133)ExperimentalParticipants will receive lemzoparlimab (TJ01133) in 28 day cycles.
  • Lemzoparlimab
Dose Escalation: Lemzoparlimab + Pomalidomide + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) + pomalidomide + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Pomalidomide
Dose Escalation: Lemzoparlimab + Carfilzomib + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) + carfilzomib + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Carfilzomib
Dose Escalation: Lemzoparlimab + Daratumumab + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) + daratumumab + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Daratumumab
Dose Expansion: LemzoparlimabExperimentalParticipants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion in 28 day cycles.
  • Lemzoparlimab
Dose Expansion: Lemzoparlimab + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
Dose Expansion: Lemzoparlimab + Pomalidomide + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Pomalidomide
Dose Expansion: Lemzoparlimab + Carfilzomib + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Carfilzomib
Dose Expansion: Lemzoparlimab + Daratamumab + DexamethasoneExperimentalParticipants will receive lemzoparlimab (TJ01133) at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
  • Lemzoparlimab
  • Dexamethasone
  • Daratumumab

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 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:DLT events as described in the protocol will be assessed.

Secondary Outcome Measures

Measure:Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Time Frame:Up to approximately 2 years
Safety Issue:
Description: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.
Measure:Progression Free Survival (PFS)
Time Frame:Up to approximately 2 years
Safety Issue:
Description: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.
Measure:Duration of Response (DOR)
Time Frame:Up to approximately 2 years
Safety Issue:
Description: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.
Measure:Time to Progression (TTP)
Time Frame:Up to approximately 2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Lemzoparlimab
  • ABBV-IMAB-TJC4
  • Relapsed or refractory multiple myeloma (R/R MM)
  • Cancer
  • TJ011133
  • Multiple Myeloma

Last Updated

May 20, 2021