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Multiple MyelomaPhase 1NCT04121260

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

A Phase 1 study testing Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesChina
Study dates
25 Dec 2019to 13 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking University Third Hospital

    Beijing, 100191

  • The Third Xiangya Hospital, Central South University

    Changsha, 410013

  • Nanfang Hospital

    Guangzhou, 510515

  • Zhongda Hospital,Southeast University

    Nanjing, 210009

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300320

Other trials in China

About this study

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

The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.

Being tested
Daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    Also called JNJ-54767414

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

Study groups in NCT04121260
Study groupRoleWhat they receive
DaratumumabExperimentalParticipants 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.
Receives: Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. Maximum Observed Serum Concentration (Cmax) of Daratumumab

    Cmax is the maximum observed serum concentration.

    Measured: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)

  3. Serum Trough Concentration (Ctrough) of Daratumumab

    Ctrough is the observed concentration of daratumumab prior to the next drug administration.

    Measured: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)

Secondary outcomes (4)

  1. 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.

    Measured: Up to 2 years

  2. 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).

    Measured: Up to 2 years

  3. Time to Response

    TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria).

    Measured: Up to 2 years

  4. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start25 Dec 2019
  3. Primary completion27 Apr 2021
  4. Study completion13 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04121260
Sponsor's protocol ID
CR108638
Other IDs
54767414MMY1010
Status last verified
Dec 2023
First submitted
8 Oct 2019
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 38832105

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (AEs) and Serious AEs (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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