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Also known as BT062 , intravenous administration, BT062
BT062, administration · 3 trials · 1 indication
The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and skeletal survey will be performed.
The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.
The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD. Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions. Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available. In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level. If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped. The highest dose level at which \< 2 of 6 subjects experienced a DLT is defined as the MTD.
| Arm | Type | Description |
|---|---|---|
| BT062 | EXPERIMENTAL | BT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM |
| Name | Type | Description |
|---|---|---|
| BT062 , intravenous administration | DRUG | Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone |
| BT062 | DRUG | intravenous administration |
Inclusion Criteria * Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria * Relapsed or relapsed/refractory progressive Multiple Myeloma * Subjects who failed at least one prior therapy (BT062/Len/dex) * Subjects who failed at least tw...
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BT062 is an investigational therapy studied for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. All of its clinical testing has been in patients with relapsed or refractory multiple myeloma, meaning disease that has returned or not responded to prior treatment. It is not an approved treatment.
BT062 is being developed by ADMA Biologics Inc, which trades on the Nasdaq under the ticker ADMA. The company sponsored the clinical program evaluating BT062 in multiple myeloma, including studies of the drug given alone and in combination with other myeloma agents.
BT062 is in Phase 1 development. Three Phase 1 trials have been conducted, and all three are now completed, with no active trials currently listed. The studies were designed primarily to assess safety and to determine dosing in patients with relapsed or refractory multiple myeloma.
BT062 has been evaluated in three completed Phase 1 trials: NCT01638936, which tested BT062 with lenalidomide or pomalidomide plus dexamethasone; NCT01001442, a multi-dose safety and dose-determining study; and NCT00723359, an earlier safety and dose-determining study. Together these trials enrolled 131 patients with multiple myeloma.
Yes. BT062 and BT062 intravenous administration refer to the same investigational agent. The alternative name reflects the intravenous route by which the drug was given in its clinical trials. BT062 is a small molecule studied in multiple myeloma and is not an approved product.
The BT062 trials were open-label Phase 1 studies without randomization or blinding, and they used no control group. They enrolled adults aged 18 and older with relapsed or refractory multiple myeloma at sites in the United States. One trial combined BT062 with lenalidomide or pomalidomide and dexamethasone.