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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY1010 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Duration of Response (DOR) |
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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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100191 | China | |||
| The Third Xiangya Hospital, Central South University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38832105 | Derived | 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. |
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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
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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DOR, defined as date of onset of first response until date of disease progression or death (according to the IMWG response criteria).
| Up to 2 years |
| Time to Response | TTR, defined as the time from Cycle 1 Day 1 until onset of first response (according to the IMWG response criteria). | Up to 2 years |
| 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. | Up to 2 years |
| Changsha |
| 410013 |
| China |
| Nanfang Hospital | Guangzhou | 510515 | China |
| Zhongda Hospital,Southeast University | Nanjing | 210009 | China |
| Institute of Hematology & Blood Diseases Hospital | Tianjin | 300320 | China |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |