NCT02002598

Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma

Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Suzanne Lentzsch, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma (MM).

Detailed description

Multiple myeloma (MM) is a malignant plasma cell disorder resulting in approximately 11,000 deaths in the United States each year. It is estimated that between 60,000-80,000 people are currently under treatment for refractory or relapsed MM. Prognosis and survival have improved over the last 20 years, but the disease is still universally fatal despite efforts to develop new and more effective chemotherapeutic regimens. Therefore, new regimens need to be developed for patients prior to peripheral blood stem cell transplant and for those unable to tolerate the toxicity of transplant. An IRB-approved long-term retrospective chart review study (IRB-AAAU4389) was conducted to collect data for Outcome Measures relating to long-term analysis (up to 6.5 years).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bendamustine	Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle. Dose escalation is as follows: -1 \| 60 mg/m2 1. \| 70 mg/m2 2. \| 70 mg/m2 3. \| 90 mg/m2 4. \| 90mg/m2 5. \| 90 mg/m2
DRUG	Carfilzomib	Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days. Dose Escalation is as follows: -1 \| 27 mg/m2 1. \| 27 mg/m2 2. \| 36 mg/m2 3. \| 36 mg/m2 4. \| 45 mg/m2 5. \| 56 mg/m2
DRUG	Dexamethasone	Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-03-01
• Completion: 2023-07-01
• First posted: 2013-12-06
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study