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 a small molecule being developed for the treatment of multiple myeloma, a cancer of plasma cells. It is currently in Phase 1 clinical development and is being studied in patients with untreated multiple myeloma who are not candidates for hematopoietic stem cell transplant.
JNJ-26866138/m2 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple myeloma.
JNJ-26866138/m2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which enrolled 101 participants with multiple myeloma in Japan.
JNJ-26866138/m2 has one completed clinical trial registered as NCT00985959. This Phase 1 study evaluated the drug in untreated multiple myeloma patients who were not candidates for hematopoietic stem cell transplant. The trial enrolled 101 participants and was conducted in Japan.
Yes, JNJ-26866138/m2 is also known as bortezomib. The clinical trial NCT00985959 is titled 'A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)', confirming that JNJ-26866138/m2 refers to bortezomib.