Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens

Clinical Trial Summary

This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will receive treatment with a SC bortezomib-containing combination regimen that does not contain thalidomide or vincristine. The patients will be required to have received a prior IV bortezomib containing combination regimen that did not contain thalidomide or vincristine and that differs from the SC bortezomib-containing one. In between the time that the patient received the IV bortezomib-based combination regimen and enrollment onto this study, patients may have received other non-bortezomib-based regimens as long as these treatments did not contain thalidomide or vincristine. This study will enroll patients who have relapsed or have become refractory to their prior IV-administered bortezomib-containing combination regimen as demonstrated by progressive disease while on or following that regimen. Patients must have received 4 doses of a minimum of 1.0 mg/m2 of bortezomib administered IV in no more than 4 weeks per cycle. Patients must have received at least one cycle meeting this definition and have shown progressive disease to be considered eligible. Patients who have relapsed or have become refractory to their most recent IV bortezomib-containing combination regimen are eligible regardless of when they received that regimen, as long as they meet the above criteria.

The study will consist of a screening period, followed by up to eight open label treatment cycles, a final assessment to occur 28 days after the end of the last treatment cycle, and a follow-up period.

Primary Objectives:

• To establish the safety and tolerability of treatment with a SC bortezomib containing combination regimen for MM patients who have demonstrated progressive disease from a prior and different IV bortezomib containing combination regimen:

- To compare the incidence of PN between IV bortezomib and treatment with SC bortezomib in a subsequent anti-MM combination regimen

- To compare the severity of PN between IV bortezomib and treatment with SC bortezomib in a subsequent combination anti-MM regimen

Secondary Objectives:

- To compare the overall response rate [combined CR + very good partial response (VGPR) + PR + MR] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease from a prior and different IV bortezomib containing combination regimen

- To compare disease parameters following treatment with a SC bortezomib containing combination regimen for MM patients who have demonstrated progressive disease from a prior and different IV bortezomib containing combination regimen as follows:

- time to progression

- progression free survival

- time to first response

- duration of response

- overall survival

- To determine the incidence and severity of injection-site reactions with SC administration of bortezomib ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell