A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04121260
Collaborator
(none)
21
Enrollment
5
Locations
1
Arm
70.2
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma
Actual Study Start Date :
Dec 25, 2019
Actual Primary Completion Date :
Apr 27, 2021
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Daratumumab

Participants will receive daratumumab dose 1 subcutaneously (SC) with recombinant human hyaluronidase [rHuPH20] 30,000 units [U] that is 2,000 U/milliliter (U/mL) SC injection once weekly for the first 8 weeks Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks Cycles 3 to 6 (Days 1 and 15) or the following 16 weeks and then every 4 weeks from Cycle 7 [Day 1] in subsequent cycles, until disease progression, unacceptable toxicity, or any other reason for discontinuation. Each cycle is 28 days in duration.

Drug: Daratumumab
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Other Names:
  • JNJ-54767414
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Adverse Events (AEs) and Serious AEs [Up to 2 years]

      An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    2. Maximum Observed Serum Concentration (Cmax) of Daratumumab [Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)]

      Cmax is the maximum observed serum concentration.

    3. Serum Trough Concentration (Ctrough) of Daratumumab [At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)]

      Ctrough is the observed concentration of daratumumab prior to the next drug administration.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [Up to 2 years]

      ORR, defined as the percentage of participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria.

    2. Duration of Response (DOR) [Up to 2 years]

      DOR, defined as date of onset of first response until date of disease progression or death (according to the IMWG response criteria).

    3. Time to Response [Up to 2 years]

      TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).

    4. Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies [Up to 2 years]

      Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Multiple myeloma (MM) diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria

    • Participants must have measurable, secretory disease as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level greater than or equal to(>=)1.0 gram/deciliter (g/dL) or >= 0.5 g/dL for Immunoglobulin (Ig) A, IgD, IgE or IgM MM; or

    2. Urine M-protein level >= 200 milligram (mg)/24 hours; or

    3. Serum Ig free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio if participant does not have measurable M-protein in serum and urine

    • Relapsed or refractory MM after receiving at least 2 prior lines of therapy: Received both, a PI (>=2 cycles or 2 months of treatment) and an IMiD (>=2 cycles or 2 months of treatment)in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months); A "line of therapy" is defined as 1 or more cycles of a planned treatment program, Radiotherapy, bisphosphonate therapy, or a single short course of steroids (that is, less than or equal to equivalent of cumulative dose of dexamethasone 160 mg within 21 days of 1st dose) would not be considered prior lines of therapy

    • Response (partial response or better based on investigator's determination of response) to at least 1 prior treatment regimen

    • Progressive disease based on investigator's determination of response on or after their last regimen

    • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

    Exclusion Criteria:
    • Participant has received daratumumab or other anti-CD38 therapies previously

    • Participant has received prior antitumor therapy as follows, prior to the first dose of study drug:

    1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less;

    2. Monoclonal antibody treatment for multiple myeloma within 21 days;

    3. Cytotoxic therapy within 21 days;

    4. Proteasome inhibitor therapy within 14 days;

    5. Immunomodulatory agent therapy within 7 days;

    6. Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5 percent (%) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy

    • Participant has had a plasmapheresis within 28 days before Cycle 1 Day 1

    • Participant has known meningeal or central nervous system involvement of MM

    • Concurrent medical condition or disease (example [e.g.], active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Peking University Third HospitalBeijingChina100191
    2The Third Xiangya Hospital, Central South UniversityChangshaChina410013
    3Nanfang HospitalGuangzhouChina510515
    4Zhongda Hospital,Southeast UniversityNanjingChina210009
    5Institute of Hematology & Blood Diseases HospitalTianjinChina300320

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04121260
    Other Study ID Numbers:
    • CR108638
    • 54767414MMY1010
    First Posted:
    Oct 9, 2019
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021