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

NCT04121260 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10863854767414MMY1010
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (4)

• Overall Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Time to Response

  Up to 2 years

• Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies

  Up to 2 years

Study Arms (1)

Daratumumab

EXPERIMENTAL

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.

Drug: Daratumumab

Interventions

Daratumumab DRUG

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

Also known as: JNJ-54767414

Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Peking University Third Hospital

Beijing, 100191, China

Location

The Third Xiangya Hospital, Central South University

Changsha, 410013, China

Location

Nanfang Hospital

Guangzhou, 510515, China

Location

Zhongda Hospital,Southeast University

Nanjing, 210009, China

Location

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300320, China

Location

Related Publications (1)

• An G, Ge Z, Jing H, Liu J, Yang G, Feng R, Xu Z, Qi M, Wang J, Song J, Zhou W, Sun B, Zhu D, Chen X, Cui C, Qiu L. Subcutaneous daratumumab in Chinese patients with relapsed or refractory multiple myeloma: an open-label, multicenter, phase 1 study (MMY1010). Blood Sci. 2024 May 31;6(3):e00193. doi: 10.1097/BS9.0000000000000193. eCollection 2024 Jul.

  PMID: 38832105 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: December 25, 2019
• Primary Completion: April 27, 2021
• Study Completion: October 13, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (5)