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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY1006 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab with Lenalidomide and dexamethasone | Experimental | Daratumumab (16 milligram per kilogram [mg/kg]) will be administered by intravenous [IV] infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants will receive dexamethasone 40mg weekly, at day 1, 8, 15, 22 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab (16 mg/kg) | Drug | Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone | Number of Participants With Dose Limiting Toxicity During Cycle 1. | Cycle 1, Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Response (CR) or Better | CR is Defined as the proportion of Participants achieving CR (including stringent complete response [sCR]) according to the International Myeloma Working Group (IMWG) criteria. | Approximately 3.7 years |
| Overall Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32002821 | Derived | Takamatsu H, Iida S, Shibayama H, Shibayama K, Yamazaki H, Suzuki K. Daratumumab, lenalidomide, and dexamethasone in Japanese patients with transplant-ineligible newly diagnosed multiple myeloma: a phase 1b study. Int J Hematol. 2020 May;111(5):692-701. doi: 10.1007/s12185-020-02825-w. Epub 2020 Jan 30. |
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| Lenalidomide | Drug | Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours. |
|
| Dexamethasone | Drug | Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle. |
|
ORR is defined as the percentage of participants who achieve CR, Partial Response (PR), VGPR, and sCR according to the IMWG criteria, during or after study treatment. |
| Approximately 3.7 years |
| Very good partial response (VGPR) or better (VGPR, CR, or sCR) | VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 pecent (%) reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram(mg)/24 hour (h). | Approximately 3.7 years |
| Minimum Observed Serum Concentration (Cmin) | The Cmin is the minimum observed analyte concentration. | Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose) |
| Maximum Observed Concentration (Cmax) | The Cmax is the maximum observed analyte concentration. | Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose) |
| Immunogenicity of daratumumab | Anti-daratumumab antibodies will be evaluated in serum samples collected for all the participants. | Cycle 1, Cycle 3, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose) |
| Kanazawa |
| Japan |
| Nagoya | Japan |
| Osaka | Japan |
| Shibuya City | Japan |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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