Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04121260 | COMPLETED | Multiple Myeloma

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

Janssen Research & Development, LLC

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 disease

Multiple Myeloma

Intervention/treatment

Daratumumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 21 participants
Masking : NONE
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 : 2019-12-25
Estimated Primary Completion Date : 2021-04-27
Estimated Study Completion Date : 2023-10-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

Location Details

NCT04121260

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

Peking University Third Hospital

Beijing, China, 100191

Not yet recruiting

China,

The Third Xiangya Hospital, Central South University

Changsha, China, 410013

Not yet recruiting

China,

Nanfang Hospital

Guangzhou, China, 510515

Not yet recruiting

China,

Zhongda Hospital,Southeast University

Nanjing, China, 210009

Not yet recruiting

China,

Institute of Hematology & Blood Diseases Hospital

Tianjin, China, 300320