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

Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT04895410
Collaborator
(none)
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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 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 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 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 :
Jan 17, 2022
Actual Primary Completion Date :
Jun 24, 2022
Actual Study Completion Date :
Jun 24, 2022

Arms and Interventions

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.

    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 + 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.

    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 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 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Cancer Center - Tucson /ID# 229696 Tucson Arizona United States 85724
    2 Yale University /ID# 230438 New Haven Connecticut United States 06510
    3 Sylvester Comprehensive Cancer Center /ID# 228817 Miami Florida United States 33136-1002
    4 Moffitt Cancer Center /ID# 229939 Tampa Florida United States 33612-9416
    5 University of Kentucky Markey Cancer Center /ID# 229506 Lexington Kentucky United States 40536-7001
    6 Norton Cancer Institute - St Matthews /ID# 229319 Louisville Kentucky United States 40207
    7 Tulane Cancer Center Clinic /ID# 229832 New Orleans Louisiana United States 70112
    8 University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309 Ann Arbor Michigan United States 48109
    9 Henry Ford Health System /ID# 230341 Detroit Michigan United States 48202
    10 Rutgers Cancer Institute of New Jersey /ID# 230174 New Brunswick New Jersey United States 08901
    11 Columbia University Medical Center /ID# 229971 New York New York United States 10032-3729
    12 Duke University Hospital /ID# 229564 Durham North Carolina United States 27710
    13 Wake Forest Baptist Health /ID# 229996 Winston-Salem North Carolina United States 27157-0001
    14 Perelman Center for Advanced Medicine - /ID# 228693 Philadelphia Pennsylvania United States 19104-5127
    15 Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473 Dallas Texas United States 75246-2003
    16 University of Texas Southwestern Medical Center /ID# 228830 Dallas Texas United States 75390-7208
    17 University of Virginia /ID# 229396 Charlottesville Virginia United States 22908
    18 Concord Hospital /ID# 229351 Concord New South Wales Australia 2139
    19 Princess Alexandra Hospital /ID# 229343 Woolloongabba Queensland Australia 4102
    20 The Queen Elizabeth Hospital /ID# 229345 Woodville South South Australia Australia 5011
    21 Royal Hobart Hospital /ID# 229348 Hobart Tasmania Australia 7000
    22 Box Hill Hospital /ID# 240762 Box Hill Victoria Australia 3128
    23 St Vincent's Hospital Melbourne /ID# 229349 Fitzroy Melbourne Victoria Australia 3065
    24 Austin Health /ID# 229352 Heidelberg Victoria Australia 3084
    25 Alfred Health /ID# 229347 Melbourne Victoria Australia 3004
    26 HCL - Hôpital Lyon Sud /ID# 229834 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    27 CHU de Nantes, Hotel Dieu -HME /ID# 228559 Nantes Pays-de-la-Loire France 44000
    28 CHU Poitiers - La milétrie /ID# 229833 Poitiers Poitou-Charentes France 86000
    29 Hopital Henri Mondor /ID# 228562 Creteil France 94000
    30 Universitaetsklinik Heidelberg /ID# 229145 Heidelberg Baden-Wuerttemberg Germany 69120
    31 Robert-Bosch-Krankenhaus /ID# 230290 Stuttgart Baden-Wuerttemberg Germany 70736
    32 Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291 Berlin Germany 12203
    33 Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141 Hamburg Germany 20246
    34 Asklepios Klinik Altona /ID# 229143 Hamburg Germany 22763
    35 Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007 Munich Germany 81675
    36 The Chaim Sheba Medical Center /ID# 229483 Ramat Gan Tel-Aviv Israel 5265601
    37 Tel Aviv Sourasky Medical Center /ID# 229478 Tel Aviv-Yafo Tel-Aviv Israel 6423906
    38 Rambam Health Care Campus /ID# 229485 Haifa Israel 3109601
    39 Hadassah Medical Center-Hebrew University /ID# 229477 Jerusalem Israel 91120
    40 Meir Medical Center /ID# 229480 Kfar Saba Israel 4428164
    41 Rabin Medical Center /ID# 229488 Petakh Tikva Israel 4941492
    42 Nagoya City University Hospital /ID# 241835 Nagoya shi Aichi Japan 467-8602
    43 National Cancer Center Hospital East /ID# 241834 Kashiwa-shi Chiba Japan 277-8577
    44 Kyushu University Hospital /ID# 241911 Fukuoka-shi Fukuoka Japan 812-8582
    45 Gunma University Hospital /ID# 241837 Maebashi-shi Gunma Japan 371-8511
    46 National Hospital Organization Mito Medical Center /ID# 244043 Higashi Ibaraki-gun Ibaraki Japan 311-3193
    47 University Hospital Kyoto Prefectural University of Medicine /ID# 241833 Kyoto-shi Kyoto Japan 602-8566
    48 Japanese Red Cross Medical Center /ID# 241836 Shibuya-ku Tokyo Japan 150-8935
    49 Hospital Clínico Universitario de Santiago-CHUS /ID# 229356 Santiago de Compostela A Coruna Spain 15706
    50 Hospital Unversitario Marques de Valdecilla /ID# 229354 Santander Cantabria Spain 39008
    51 Hospital Parc de Salut del Mar /ID# 229371 Barcelona Spain 08003
    52 Hospital Santa Creu i Sant Pau /ID# 229369 Barcelona Spain 08041
    53 Hospital Universitario Reina Sofia /ID# 229388 Cordoba Spain 14004
    54 Hospital Universitario 12 de Octubre /ID# 229355 Madrid Spain 28041
    55 University Hospital Southampton NHS Foundation Trust /ID# 228332 Southampton Hampshire United Kingdom SO16 6YD
    56 Guy's and St Thomas' NHS Foundation Trust /ID# 228323 London London, City Of United Kingdom SE1 9RT
    57 Oxford University Hospitals NHS Foundation Trust /ID# 228328 Oxford Oxfordshire United Kingdom OX3 9DU
    58 Leeds Teaching Hospitals NHS Trust /ID# 228333 Leeds United Kingdom LS9 7TF
    59 The Christie Hospital /ID# 228330 Manchester United Kingdom M20 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:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    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 Jul 8, 2022