Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease

NCT01410500 | Unknown

• 1 other identifier: 2011-002
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to expand upon the safety data for carfilzomib by providing expanded access to patients with relapsed and refractory multiple myeloma who are unable to enroll in any other ongoing carfilzomib trial.

Conditions

Multiple Myeloma

Keywords

multiple myeloma

Interventions

Carfilzomib DRUG

Carfilzomib was administered as an intravenous (IV) infusion over approximately 10 minutes on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles at a dose of 20 mg/m² on Days 1 and 2 of Cycle 1 and 27 mg/m² for all infusions thereafter until Cycle 12. For Cycle 13 and higher for those still receiving carfilzomib, the carfilzomib infusion schedule was abridged to Days 1, 2, 15, and 16 of each subsequent 28-day cycle. Carfilzomib treatment was continued until disease progression, diagnosis of a new malignancy, unacceptable toxicity, withdrawal of consent, or the study was terminated

Also known as: Kyprolis®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented multiple myeloma
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) status 0-2.
• Life expectancy ≥ 3 months.
• Measurable disease, defined as one or more of the following:
• Serum M-protein ≥ 1 g/dL.
• Urine M-protein ≥ 200 mg/24 hours.
• For Immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA), ≥ 750 mg/dl (0.75 g/dl).
• For oligosecretory or non-secretory MM, either of the following:
• Measurable plasmacytoma \> 2 cm as determined by clinical examination or applicable radiographs (ie, magnetic resonance imaging \[MRI\], computed tomography \[CT\] scan).
• Documented abnormal free light chain ratio (NV: 0.26 to 1.65) or a value beyond the laboratory calculation range.
• Received and either refractory or relapsed or discontinued due to toxicity to at least 4 prior lines of therapy as described below:
• an immunomodulatory agent (lenolidamide or thalidomide)
• bortezomib
• an alkylating agent (standard or high dose)

You may not qualify if:

• Prior treatment with carfilzomib or enrollment in any other Phase 3 carfilzomib trial.
• Known human immunodeficiency virus (HIV) seropositivity.
• Active infection requiring systemic treatment with anti-biotics, anti-virals, or anti-fungals.
• Known, active hepatitis A, B, or C viral infection.
• Concomitant use of approved or investigational anti-cancer therapeutic agents, other than dexamethasone or palliative radiation therapy. Patients receiving radiation for pain control are eligible for enrollment in this study. No wash-out period is required for other anti-myeloma treatments received.
• Concomitant use of other investigational agents (eg, anti-biotics or anti-emetics).
• Pregnancy or breastfeeding.
• History of plasma cell leukemia, defined as \> 2.0 × 10ˆ9/L circulating plasma cells.
• History of amyloidosis.
• Known history of allergy to Captisol®.
• Active congestive heart failure (New York Heart Association Class 3-4), symptomatic ischemia, conduction abnormalities uncontrolled by a conventional intervention, or a myocardial infarction within the past 4 months.
• Intolerance to hydration due to pre-existing pulmonary, cardiac, or renal impairment. Patients on hemodialysis should be considered as meeting this criterion for entry.
• Waldenström macroglobulemia or immunoglobulin M (IgM) myeloma.

Sponsors & Collaborators

• Amgen: lead
• Multiple Myeloma Research Foundation: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 5, 2011
• Last Updated: May 2, 2017

Record last verified: 2017-04