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Multiple MyelomaPhase 1NCT03242889

A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing DARA SC in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 5 sites in Japan.

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 tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
DARA SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
5 sitesJapan
Study dates
10 Aug 2017to 10 Feb 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant proven to have Multiple Myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Participant must have measurable, secretory disease as defined by any of the following:
  • Immunoglobulin (Ig) G MM: serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg)/24 hours; or
  • IgA, IgD, IgE MM: serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hours; or
  • Light chain MM, for participants without measurable disease in the serum or urine: serum Ig free light chains (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
  • Participant must have received >= 2 prior lines of antimyeloma therapy without further established treatment option
Show all 19Show fewer
  • Participant must have relapsed or refractory disease
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • The Participant must meet the following criteria of clinical laboratory test results during screening phase:
  • hemoglobin >=7.5 g/dL (>=5 millimoles/liter [mmol/L]) (without prior Red Blood Cells (RBC) transfusion within 7 days before the laboratory test;
  • absolute neutrophil count (ANC) >=1.0*10^9/L (without granulocyte colony stimulating factor support in the 7 days prior the laboratory test);
  • platelet count >=75*10^9/L for participants in whom less than (<)50.0 percent (%) of bone marrow nucleated cells are plasma cells; otherwise platelet count >=50*10^9/L (without transfusion support in the 7 days prior to the laboratory test);
  • aspartate aminotransferase (AST) less than or equal to (<=)3.0 times upper limit of normal (ULN);
  • alanine aminotransferase (ALT) <=3.0 times ULN;
  • creatinine clearance >20 mL/minute/1.73 m^2;
  • total bilirubin <=2.0 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 times ULN is required);
  • corrected serum calcium <=14 mg/dL (<=3.5 mmol/L)
  • Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective methods of reliable birth control. Contraception must begin 4 weeks before initiating treatment, during therapy, during dose interruptions, and continue for 6 months following discontinuation of study therapy
  • A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control, even if he had a successful vasectomy, for example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the final dose of study drug

Who cannot join

  • Participant has received daratumumab or other anti cluster of differentiation (CD)38 therapies previously
  • Participant has received antimyeloma treatment within 2 weeks before Cycle 1 Day 1
  • Participant has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle 1 Day 1, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
  • Participant has received a cumulative dose of corticosteroids equivalent or more than the equivalent of 140 mg of prednisolone within the 2-week period before Cycle 1 Day 1
  • Participant has a history of malignancy (other than MM) within 3 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • National Hospital Organization Shibukawa Medical Center

    Gunma, 377-0280

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • Ogaki Municipal Hospital

    Ohgaki, 503-8502

  • Osaka University Hospital

    Osaka, 565-0871

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

Other trials in Japan

About this study

Official title: A Phase 1 Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).

Being tested
DARA SC
Medical subject headings
Multiple Myeloma

What participants receive

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

  • DARA SCDrug

    Participants will receive 1800 mg daratumumab with 30,000 U (2000 U/mL) rHuPH20 SC injection once weekly for the first 8 weeks in Cycles 1 and 2 and every 2 weeks in Cycles 3 to 6 for 16 weeks and then every 4 weeks in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation.

Study groups in NCT03242889
Study groupRoleWhat they receive
DARA SCExperimentalParticipants will receive DARA SC (daratumumab 1800 milligram [mg] with Recombinant Human Hyaluronidase [rHuPH20] 30,000 units [U] that is 2000 U/milliliter [U/mL]) subcutaneous (SC) injection once weekly for the first 8 weeks in Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks in Cycles 3 to 6 (Days 1 and 15) for 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: DARA SC

What is being measured

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

  1. Number of Participants With Adverse Events Including Dose Limiting Toxicity

    An adverse event (AE) is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

    Measured: Up to 30 days after last study drug dose (approximately up to 1 year)

Secondary outcomes (6)

  1. Maximum Observed Concentration (Cmax) of Daratumumab

    Maximum observed concentration of daratumumab will be measured.

    Measured: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)

  2. Maximum Serum Trough Concentration (Ctrough) of Daratumumab

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

    Measured: At Cycle 3 Day 1 predose concentration

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

    Serum levels of antibodies to daratumumab and rHuPH20 will be analyzed for evaluation of potential immunogenicity.

    Measured: Up to 8 weeks after the last dose of study drug (approximately up to 1 year)

  4. Overall Response Rate

    Overall Response is partial response (PR)/better as per International Myeloma Working Group (IMWG) criteria. PR: >=50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to <200 mg/24 hours; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chains (FLC) levels; if serum and urine M-protein and serum free light assay is not measurable, >=50% reduction in bone marrow plasma cell (PC), with baseline bone marrow PC percentage >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas; Very good partial response: serum and urine M-component detectable by immunofixation or >=90.0% reduction in serum M-protein and urine M-protein <100mg/24 hours; Complete response (CR):negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5.0% PCs in bone marrow; Stringent complete response (sCR): CR plus normal FLC ratio and absence of clonal PCs.

    Measured: Approximately up to 1 year

  5. Duration of Response (DOR)

    DOR is date of first documentation of confirmed PR or better to date of first documented PD (as per IMWG criteria), or date of death due to PD, whichever occurs first. PD: 25% increase from lowest response value in 1 of following: serum M-component, urine M-component (absolute increase must be >= 0.5 gram per deciliter [g/dL], >= 200 mg/24 hours respectively), Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase must be >10 milligram per deciliter (mg/dL), only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) attributed solely to PC proliferative disorder.

    Measured: First documentation of confirmed PR or better to the date of first documented progressive disease (PD), or date of death due to PD, whichever occurs first (approximately up to 1 year)

  6. Time to Response

    Time to response is defined as the time between Cycle 1 Day 1 and the first efficacy evaluation date that the participant has met all criteria for PR or better (as per IMWG criteria). PR: >=50% reduction of serum M-protein, >=90% reduction in 24 hour urinary M-protein or to <200 mg/24 hours; if serum and urine M-protein are not measurable, >=50% decrease in difference between involved and uninvolved FLC levels; if serum and urine M-protein and serum free light assay is not measurable, >=50% reduction in bone marrow PC, with baseline bone marrow PC percentage >=30%; if present at baseline, >=50% reduction in size of soft tissue plasmacytomas; Very good partial response: serum and urine M-component detectable by immunofixation or >=90.0% reduction in serum M-protein and urine M-protein <100mg/24 hours; CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5.0% PCs in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs.

    Measured: Approximately up to 1 year

Timeline

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

  1. First posted8 Aug 2017
  2. Study start10 Aug 2017
  3. Primary completion1 Nov 2017
  4. Study completion10 Feb 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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242889
Sponsor's protocol ID
CR108337
Other IDs
54767414MMY1008
Status last verified
Apr 2023
First submitted
4 Aug 2017
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6.

    PubMed 37022569

  • Shibayama H, Matsumoto M, Kosugi H, Shibayama K, Yamazaki H, Iida S. Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2021 Jan;113(1):112-121. doi: 10.1007/s12185-020-02985-9. Epub 2020 Sep 11.

    PubMed 32915384

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DARA SC in people with Multiple Myeloma, run by Janssen Pharmaceutical K.K. at 5 sites in Japan.

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 19 inclusion and 5 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 14 Apr 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 Japan. 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 Including Dose Limiting Toxicity (time frame: Up to 30 days after last study drug dose (approximately up to 1 year)). 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 NCT03242889, which also lists 2 linked publications.

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 14 Apr 2023.

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