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Completed

NCT Number: NCT04121260

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • Urine M-protein level >= 200 milligram (mg)/24 hours; or
  • 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:
  • 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;
  • Monoclonal antibody treatment for multiple myeloma within 21 days;
  • Cytotoxic therapy within 21 days;
  • Proteasome inhibitor therapy within 14 days;
  • Immunomodulatory agent therapy within 7 days;
  • 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

Treatment and study plan

Daratumumab

Drug

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

Other names: JNJ-54767414

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Oct 9, 2019
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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