Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments

Phase 1

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT01365559
• Lead Sponsor: Oncotherapeutics

Brief Summary

This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the same bortezomib-containing combination regimen to which a MM patient has progressed while receiving. This study will enroll 45 patients total. These patients will be resistant to bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within 12 weeks of the last dose of bortezomib in a combination regimen. Patients will be sub-divided into 2 groups in this study, treatments containing (Group A) or not containing immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15 patients into Group B for a total of 45 patients. Patients must have received 4 doses of a minimum of 1.0 mg/m\^2 of bortezomib 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 been refractory to or relapsed within 12 weeks of the last dose of bortezomib in their most recent bortezomib-containing regimen that does not include either thalidomide or lenalidomide are eligible regardless of when patients received that regimen, as long as they meet the above criteria.

Carfilzomib will subsequently replace bortezomib using the patient's most recent bortezomib-containing regimen to which the patient progressed while receiving. Patients will be eligible if they progressed from bortezomib with an alkylating agent (melphalan or cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or lenalidomide). 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, a follow-up period and maintenance cycles of single agent carfilzomib.

Patient who complete the combination treatment period without progressive disease will be eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy carfilzomib will be administered at the same dose given during the last cycle of combination treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-02
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2014-06-13
• Study Completion: 2016-03-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Establish MTD, determine DLT and to determine the efficacy as assessed by the overall response rate.	Montly	Phase I: • To establish the maximum tolerated dose (MTD) and determine the dose limiting toxicities (DLT) following treatment.; Phase II: • To determine the efficacy as assessed by the overall response rate \[CR + VGPR + PR + MR\] and the Time to Progression (TTP) of disease.

Secondary Outcome Measures

Name	Time	Method
To establish safety and efficacy following treatment.	Montly	Phase I: Obtain preliminary evidence of efficacy following treatment based on: * SPEP, UPEP and quantification of serum immunoglobulins; * Bone marrow aspirates \& biopsies; * B2M; * A roentgenographic skeletal survey of bones; Phase II: Establish the safety \& tolerability following treatment based on: * Adverse events; * Clinical lab tests; * Vital signs; * Medical history \& body weight measurements; * ECOG performance status; * Concomitant medication usage; Both phases: Progression Free Survival among patients who continue onto maintenance treatment

Trial Locations

Locations (9)

Pacific Oncology and Hematology; 🇺🇸 Encinitas, California, United States

Pacific Cancer Care; 🇺🇸 Salinas, California, United States

Central Coast Medical Oncology; 🇺🇸 Santa Maria, California, United States

James R. Berenson, MD, Inc.; 🇺🇸 West Hollywood, California, United States

Cancer Centers of America; 🇺🇸 Zion, Illinois, United States

Franciscan St. Francis Health; 🇺🇸 Indianapolis, Indiana, United States

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Family Cancer Center Foundation, Inc.; 🇺🇸 Memphis, Tennessee, United States

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States