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Also known as Indatuximab ravtansine
BT062 · 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 small molecule studied for the treatment of multiple myeloma. It was evaluated in patients with relapsed or refractory multiple myeloma, and in one study it was given in combination with lenalidomide or pomalidomide plus dexamethasone. All of its clinical trials have been completed.
BT062 was developed by ADMA Biologics Inc, which trades under the ticker ADMA. The company sponsored the clinical program for BT062 in multiple myeloma, which included three completed studies conducted in the United States.
BT062 reached Phase 1 and Phase 1/2 clinical development in multiple myeloma. All three of its trials are listed as completed, and none are currently active. BT062 is an investigational agent and is not described as an approved therapy.
BT062 was studied in three completed trials: NCT01638936, which combined BT062 with lenalidomide or pomalidomide and 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.
BT062 was given by intravenous administration in its clinical studies. The trials evaluated multiple dose levels of BT062 in patients with relapsed or refractory multiple myeloma, with the dose-determining studies designed to establish the safety profile and appropriate dosing of the intravenous regimen.
Yes. BT062, BT062 intravenous administration, and the alternate spelling BT062 all refer to the same investigational agent developed by ADMA Biologics for multiple myeloma. The intravenous form describes how the drug was given in its clinical trials rather than a separate product.