Clinical trial NCT04121260: A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma
Official title: A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with Adverse Events (AEs) and Serious AEs
timeFrame: Up to 2 years
measure: Maximum Observed Serum Concentration (Cmax) of Daratumumab
timeFrame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
measure: Serum Trough Concentration (Ctrough) of Daratumumab
timeFrame: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Time to Response
timeFrame: Up to 2 years
measure: Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital, Central South University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: