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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121260
• Other study ID #: CR108638
• Secondary ID: 54767414MMY1010
• Status: Completed
• Phase: Phase 1
• Start date: December 25, 2019
• Est. completion date: October 13, 2023

Study information

• Verified date: December 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 13, 2023
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	The Third Xiangya Hospital, Central South University	Changsha
China	Nanfang Hospital	Guangzhou
China	Zhongda Hospital,Southeast University	Nanjing
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 years
Primary	Maximum Observed Serum Concentration (Cmax) of Daratumumab	Cmax is the maximum observed serum concentration.	Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
Primary	Serum Trough Concentration (Ctrough) of Daratumumab	Ctrough is the observed concentration of daratumumab prior to the next drug administration.	At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)
Secondary	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.	Up to 2 years
Secondary	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).	Up to 2 years
Secondary	Time to Response	TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).	Up to 2 years
Secondary	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.	Up to 2 years