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

Overview

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

Full Title of Study: “A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 20, 2021

Interventions

  • Drug: Daratumumab
    • Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with Adverse Events (AEs) and Serious AEs
    • Time Frame: 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.
  • Maximum Observed Serum Concentration (Cmax) of Daratumumab
    • Time Frame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
    • Cmax is the maximum observed serum concentration.
  • Serum Trough Concentration (Ctrough) of Daratumumab
    • Time Frame: 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 Measures

  • Overall Response Rate (ORR)
    • Time Frame: 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.
  • Duration of Response (DOR)
    • Time Frame: 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).
  • Time to Response
    • Time Frame: 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).
  • Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
    • Time Frame: Up to 2 years
    • Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.

Participating in This Clinical Trial

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

  • 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 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Research & Development, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC
  • Overall Contact(s)
    • Study Contact, 844-434-4210, JNJ.CT@sylogent.com

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