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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04895410
Collaborator
(none)
170
Enrollment
49
Locations
9
Arms
46.9
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 13, 2021
Anticipated Primary Completion Date :
Aug 10, 2025
Anticipated Study Completion Date :
Aug 10, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Dose Escalation: Lemzoparlimab (TJ01133)

Participants will receive lemzoparlimab (TJ01133) in 28 day cycles.

Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
  • TJ011133
  • Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone

    Participants will receive lemzoparlimab (TJ01133) + 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 (TJ01133) + carfilzomib + dexamethasone in 28 day cycles.

    Biological: Lemzoparlimab
    Intravenous (IV) infusion
    Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • TJ011133
  • Drug: Dexamethasone
    Oral tablet or IV infusion/injection

    Biological: Daratumumab
    Subcutaneous (SC) injection

    Outcome Measures

    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) [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 [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) [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) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Arizona Cancer Center - Tucson /ID# 229696TucsonArizonaUnited States85724
    2Yale University /ID# 230438New HavenConnecticutUnited States06510
    3Sylvester Comprehensive Cancer /ID# 228817MiamiFloridaUnited States33136-1002
    4Moffitt Cancer Center /ID# 229939TampaFloridaUnited States33612-9416
    5University of Kentucky Markey Cancer Center /ID# 229506LexingtonKentuckyUnited States40536-7001
    6Norton Cancer Institute - St Matthews /ID# 229319LouisvilleKentuckyUnited States40207
    7Tulane Cancer Center Clinic /ID# 229832New OrleansLouisianaUnited States70112
    8Massachusetts General Hospital /ID# 229326BostonMassachusettsUnited States02114
    9University of Michigan Health Systems /ID# 229309Ann ArborMichiganUnited States48109
    10Henry Ford Health System /ID# 230341DetroitMichiganUnited States48202
    11Rutgers Cancer Institute of New Jersey /ID# 230174New BrunswickNew JerseyUnited States08901
    12Columbia University Medical Center /ID# 229971New YorkNew YorkUnited States10032-3729
    13Duke University Hospital /ID# 229564DurhamNorth CarolinaUnited States27710
    14Perelman Center for Advanced Medicine - /ID# 228693PhiladelphiaPennsylvaniaUnited States19104-5127
    15Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473DallasTexasUnited States75246-2003
    16University of Texas Southwestern Medical Center /ID# 228830DallasTexasUnited States75390-7208
    17University of Virginia /ID# 229396CharlottesvilleVirginiaUnited States22908
    18Concord Hospital /ID# 229351ConcordNew South WalesAustralia2139
    19Princess Alexandra Hospital /ID# 229343WoolloongabbaQueenslandAustralia4102
    20The Queen Elizabeth Hospital /ID# 229345Woodville SouthSouth AustraliaAustralia5011
    21Royal Hobart Hospital /ID# 229348HobartTasmaniaAustralia7000
    22Alfred Health /ID# 229347MelbourneVictoriaAustralia3004
    23HCL - Hôpital Lyon Sud /ID# 229834Pierre Benite CEDEXAuvergne-Rhone-AlpesFrance69495
    24CHU de Nantes, Hotel Dieu -HME /ID# 228559NantesPays-de-la-LoireFrance44000
    25CHU Poitier - La milétrie /ID# 229833PoitiersPoitou-CharentesFrance86000
    26Hopital Henri Mondor /ID# 228562CreteilFrance94000
    27Universitaetsklinik Heidelberg /ID# 229145HeidelbergBaden-WuerttembergGermany69120
    28Robert-Bosch-Krankenhaus /ID# 230290StuttgartBaden-WuerttembergGermany70736
    29Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291BerlinGermany12203
    30Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141HamburgGermany20246
    31Asklepios Klinik Altona /ID# 229143HamburgGermany22763
    32Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007MunichGermany81675
    33The Chaim Sheba Medical Center /ID# 229483Ramat GanTel-AvivIsrael5265601
    34Tel Aviv Sourasky Medical Center /ID# 229478Tel Aviv-YafoTel-AvivIsrael6423906
    35Rambam Health Care Campus /ID# 229485HaifaIsrael3109601
    36Hadassah Medical Center-Hebrew University /ID# 229477JerusalemIsrael91120
    37Meir Medical Center /ID# 229480Kfar SabaIsrael4428164
    38Rabin Medical Center /ID# 229488Petakh TikvaIsrael4941492
    39Hospital Clínico Universitario de Santiago-CHUS /ID# 229356Santiago de CompostelaA CorunaSpain15706
    40Hospital Unversitario Marques de Valdecilla /ID# 229354SantanderCantabriaSpain39008
    41Hospital Parc de Salut del Mar /ID# 229371BarcelonaSpain08003
    42Hospital Santa Creu i Sant Pau /ID# 229369BarcelonaSpain08041
    43Hospital Universitario Reina Sofia /ID# 229388CordobaSpain14004
    44Hospital Universitario 12 de Octubre /ID# 229355MadridSpain28041
    45University Hospital Southampton NHS Foundation Trust /ID# 228332SouthamptonHampshireUnited KingdomSO16 6YD
    46Guy's and St Thomas' NHS Foundation Trust /ID# 228323LondonLondon, City OfUnited KingdomSE1 9RT
    47Oxford University Hospitals NHS Foundation Trust /ID# 228328OxfordOxfordshireUnited KingdomOX3 9DU
    48Leeds Teaching Hospitals NHS Trust /ID# 228333LeedsUnited KingdomLS9 7TF
    49The Christie Hospital /ID# 228330ManchesterUnited KingdomM20 4BX

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04895410
    Other Study ID Numbers:
    • M20-917
    • 2021-001067-24
    First Posted:
    May 20, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021