A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2/3

Condition

Cancer/tumors

Lymphoproliferative Disorders

Platelet Disorders

Treatment

JNJ-63723283

Daratumumab

Clinical Study ID

NCT03357952
CR108381
54767414MMY2036
2017-002611-34
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course oftreatment for multiple myeloma or have disease that is refractory to both a PI andan IMiD

  • Evidence of a response (partial response [PR] or better based on investigator'sdetermination of response by International Myeloma Working Group [IMWG] criteria) toat least 1 prior treatment regimen

  • Documented measurable disease for multiple myeloma at screening as defined inprotocol

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

  • Contraceptive use by men or women should be consistent with local regulationsregarding the use of contraceptive methods for participants participating inclinical studies

Exclusion

Exclusion Criteria:

  • Received any of the following prescribed medications or therapies in the past:Anti-CD38 antibody, including daratumumab, and/or Anti-PD-1 (programmed death-1) andanti-PD-L1 (programmed death-ligand 1) antibodies

  • Plans to undergo a stem cell transplant prior to progression of disease on thisstudy (these participants should not be enrolled to reduce disease burden prior totransplant)

  • History of malignancy (other than multiple myeloma) within 2 years prior to firstadministration of study drug (exceptions are squamous and basal cell carcinomas ofthe skin and carcinoma in situ of the cervix, or malignancy that in the opinion ofthe investigator, with concurrence with the sponsor's medical monitor, is consideredcured with minimal risk of recurrence within 3 years)

  • Clinical signs of meningeal involvement of multiple myeloma

  • Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volumein 1 second (FEV1) <50% of predicted normal or known moderate or severe persistentasthma within the past 2 years, or uncontrolled asthma of any classification

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: JNJ-63723283
Phase: 2/3
Study Start date:
November 16, 2017
Estimated Completion Date:
November 19, 2021

Study Description

This is a multi-phase study of JNJ-63723283 in combination with daratumumab compared with daratumumab alone in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD. The study consists of Screening Phase (procedures performed within 28 days before enrollment), Open-Label Treatment Phase (with End-of-Treatment Visit to occur 4 weeks after the last dose of study treatment) and Follow-up phase (8 weeks after the last dose of study treatment). Ongoing safety evaluation during Part 1 and Part 2 will be overseen by the Safety Evaluation Team (SET). In Part 3, ongoing safety and efficacy evaluation will be performed by the Independent Data Monitoring Committee (IDMC).

Connect with a study center

  • ZNA Stuivenberg

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930
    Belgium

    Site Not Available

  • AZ St.-Jan Brugge-Oostende AV

    Brugge, 8000
    Belgium

    Site Not Available

  • UZBrussel

    Brussel, 1090
    Belgium

    Site Not Available

  • UZA

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Az Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Instituto Do Cancer Do Ceara

    Fortaleza, 60430-230
    Brazil

    Site Not Available

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    Rio De Janeiro, 22271-110
    Brazil

    Site Not Available

  • Hospital Santa Cruz

    São Paulo, 04122-000
    Brazil

    Site Not Available

  • CHU de Limoges, Hopital Dupuytren

    Limoges, 87042
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille Cedex 9,
    France

    Site Not Available

  • CHU de Montpellier, Hopital Saint-Eloi

    Montpellier, 34295
    France

    Site Not Available

  • Chu Rennes - Hopital Pontchaillou

    Rennes Cedex, 35033
    France

    Site Not Available

  • CHU de Tours - Hôpital de Bretonneau

    Tours Cedex 9, 37044
    France

    Site Not Available

  • Helios Kliniken Berlin Buch Gmbh

    Berlin, 13125
    Germany

    Site Not Available

  • Asklepios Klinik Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • Klinische Forschung Hannover -Mitte

    Hannover, 30159
    Germany

    Site Not Available

  • Institut für Versorgungsforschung

    Koblenz, 56068
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg Universität

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum der Eberhard-Karls-Universität / Abt. für innere Med. II / Hämatologie/Onkologie - German

    Tübingen, 72076
    Germany

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28
    Greece

    Site Not Available

  • Carmel Hospital

    Haifa, 34362
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tiqva, 49100
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat-Gan, 52621
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • City clinical hospital n.a. S.P.Botkin

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Hospital

    Ryazan, 390003
    Russian Federation

    Site Not Available

  • Samara Region Clinical Hospital

    Samara, 443095
    Russian Federation

    Site Not Available

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Ankara Universitesi Tip Fakultesi

    Ankara, 06590
    Turkey

    Site Not Available

  • Trakya University Medical Faculty

    Edirne, 22030
    Turkey

    Site Not Available

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340
    Turkey

    Site Not Available

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55200
    Turkey

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Shivers Cancer Center

    Austin, Texas 78701
    United States

    Site Not Available

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