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Trial record 15 of 122 for:    daratumumab multiple myeloma

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

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ClinicalTrials.gov Identifier: NCT04121260
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Daratumumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma
Estimated Study Start Date : March 13, 2020
Estimated Primary Completion Date : July 20, 2021
Estimated Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: 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.
Drug: Daratumumab
Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
Other Name: JNJ-54767414




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Up to 2 years ]
    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.

  2. Maximum Observed Serum Concentration (Cmax) of Daratumumab [ Time Frame: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days) ]
    Cmax is the maximum observed serum concentration.

  3. Serum Trough Concentration (Ctrough) of Daratumumab [ Time Frame: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days) ]
    Ctrough is the observed concentration of daratumumab prior to the next drug administration.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    ORR, defined as the percentage of participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) response criteria.

  2. Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    DOR, defined as date of onset of first response until date of disease progression or death (according to the IMWG response criteria).

  3. Time to Response [ Time Frame: Up to 2 years ]
    TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).

  4. Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies [ Time Frame: Up to 2 years ]
    Serum levels of antibodies to Daratumumab and rHuPH20 for evaluation of potential immunogenicity will be reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121260


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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China
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
The Third Xiangya Hospital, Central South University Not yet recruiting
Changsha, China, 410013
Nanfang Hospital Not yet recruiting
Guangzhou, China, 510515
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, China, 210008
Zhongda Hospital,Southeast University Not yet recruiting
Nanjing, China, 210009
Institute of Hematology & Blood Diseases Hospital Not yet recruiting
Tianjin, China, China, 300320
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04121260     History of Changes
Other Study ID Numbers: CR108638
54767414MMY1010 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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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
Additional relevant MeSH terms:
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Multiple Myeloma
Daratumumab
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs