Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DOXIL · 2 trials · 2 indications
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Thalidomide + dexamethasone | ACTIVE_COMPARATOR | - |
| Thalidomide + dexamethasone + DOXIL | EXPERIMENTAL | - |
| DOXIL and docetaxel combination therapy | EXPERIMENTAL | DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. |
| Docetaxel monotherapy | ACTIVE_COMPARATOR | Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
| Name | Type | Description |
|---|---|---|
| Thalidomide | DRUG | Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles. |
| Dexamethasone | DRUG | Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20. |
| DOXIL | DRUG | DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1. |
| Docetaxel | DRUG | Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
Inclusion Criteria: * Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Adequate absolute neutrophil count (ANC), platelet count and hemoglobin * Adequate serum calcium ...
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DOXIL is used for the treatment of multiple myeloma, breast cancer, and other neoplasms. It is being studied in patients with advanced or refractory solid malignancies, including ovarian cancer. The drug is currently in Phase 3 clinical trials for these indications.
DOXIL is a small molecule that targets cancer cells. It is a formulation of doxorubicin, an anthracycline antibiotic that works by intercalating DNA and inhibiting topoisomerase II, leading to cell death. This mechanism is effective against rapidly dividing cancer cells.
DOXIL is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's efficacy in various oncology indications.
DOXIL is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trials are completed, and the drug is being studied for multiple myeloma and breast cancer.
DOXIL has been studied in several clinical trials, including NCT00091442, a Phase 3 study of docetaxel with or without DOXIL in advanced breast cancer, and NCT00097981, a Phase 3 study of thalidomide plus dexamethasone with or without DOXIL in newly diagnosed multiple myeloma. Both trials are completed.
Yes, DOXIL is also known as CAELYX. Clinical trials such as NCT01815294 and NCT02081495 refer to the drug as DOXIL/CAELYX, indicating that these names are used interchangeably for the same formulation of doxorubicin.