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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Daratumumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital
  • The Third Xiangya Hospital, Central South University
  • Nanfang Hospital
  • Zhongda Hospital,Southeast University
  • Institute of Hematology & Blood Diseases Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daratumumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events (AEs) and Serious AEs
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
Cmax is the maximum observed serum concentration.
Serum Trough Concentration (Ctrough) of Daratumumab
Ctrough is the observed concentration of daratumumab prior to the next drug administration.

Secondary Outcome Measures

Overall Response Rate (ORR)
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)
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
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
Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.

Full Information

First Posted
October 8, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04121260
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 25, 2019 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daratumumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
JNJ-54767414
Intervention Description
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs) and Serious AEs
Description
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.
Time Frame
Up to 2 years
Title
Maximum Observed Serum Concentration (Cmax) of Daratumumab
Description
Cmax is the maximum observed serum concentration.
Time Frame
Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
Title
Serum Trough Concentration (Ctrough) of Daratumumab
Description
Ctrough is the observed concentration of daratumumab prior to the next drug administration.
Time Frame
At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR, defined as the percentage of participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria.
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Description
DOR, defined as date of onset of first response until date of disease progression or death (according to the IMWG response criteria).
Time Frame
Up to 2 years
Title
Time to Response
Description
TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).
Time Frame
Up to 2 years
Title
Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies
Description
Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The Third Xiangya Hospital, Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
ZIP/Postal Code
300320
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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