Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 20 of 25 competitors
BT062 is an investigational small molecule being studied for the treatment of multiple myeloma. It has been evaluated in patients with relapsed or refractory multiple myeloma, both as a single agent and in combination with other therapies. The drug is currently in Phase 1 clinical development.
BT062 is being developed by ADMA Biologics Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ADMA. The company has sponsored multiple clinical trials of BT062 in patients with multiple myeloma.
BT062 is in Phase 1 clinical development. All three clinical trials of BT062 have been completed, with a total of 131 patients enrolled across the studies. The drug is investigational and has not been approved by regulatory authorities.
BT062 has been studied in three completed Phase 1 clinical trials. These include NCT00723359, a safety and dose determining study in relapsed or refractory multiple myeloma; NCT01001442, a multi-dose study in the same patient population; and NCT01638936, a study combining BT062 with lenalidomide or pomalidomide and dexamethasone.
Yes, BT062 has been studied in combination with lenalidomide or pomalidomide and dexamethasone in patients with multiple myeloma. This combination trial, NCT01638936, enrolled 64 patients and has been completed. Other trials evaluated BT062 as a single agent.