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

NCT ID: NCT04121260

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2023-10-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daratumumab

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.

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: DRUG

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

Interventions

Daratumumab

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

Intervention Type: DRUG

Other Intervention Names

JNJ-54767414

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38832105 (View on PubMed)

Other Identifiers

54767414MMY1010

Identifier Type: OTHER

Identifier Source: secondary_id

CR108638

Identifier Type: -

Identifier Source: org_study_id