Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-26866138/m2 · 1 trial · 1 indication
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions
| Arm | Type | Description |
|---|---|---|
| Phase I: JNJ-26866138 0.7 mg/m2 | EXPERIMENTAL | JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. |
| Phase I: JNJ-26866138 1.0 mg/m2 | EXPERIMENTAL | JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles |
| Phase I: JNJ-26866138 1.3 mg/m2 | EXPERIMENTAL | JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles |
| Phase II: JNJ-26866138 1.3 mg/m2 | EXPERIMENTAL | JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles |
| Name | Type | Description |
|---|---|---|
| JNJ-26866138 0.7 mg/m2 | DRUG | JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. |
| JNJ-26866138 1.0 mg/m2 | DRUG | JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles |
| JNJ-26866138 1.3 mg/m2 | DRUG | Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles. |
| Melphalan | DRUG | Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles |
| Prednisolone | DRUG | Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles |
Inclusion Criteria: * Participants diagnosed with symptomatic or nonsecretory multiple myeloma * Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates * Participants with a measurable lesion * Life expectancy greater than or equal to 3 months...
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JNJ-26866138/m2 is studied for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. The clinical program evaluated it in untreated multiple myeloma patients who were not candidates for hematopoietic stem cell transplant. It is an oncology asset developed by Johnson & Johnson.
JNJ-26866138/m2 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical program for this small molecule in multiple myeloma. It is one of the company's oncology pipeline assets.
JNJ-26866138/m2 is in Phase 1 development. It is an investigational agent and is not approved for commercial use. The Phase 1 study in multiple myeloma has been completed, and no trials for this asset are currently listed as active.
JNJ-26866138/m2 was evaluated in one Phase 1 trial, NCT00985959, titled A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT). The trial enrolled 101 patients in Japan and is completed.
The single Phase 1 trial of JNJ-26866138/m2, NCT00985959, was a controlled study without randomization or double blinding. It enrolled 101 patients aged 20 years and older with untreated multiple myeloma in Japan who were not candidates for hematopoietic stem cell transplant. The study is completed.