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

April 28, 2017 updated by: Amgen
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center, expanded access, open label study of carfilzomib for patients with relapsed and refractory multiple myeloma. The study is designed to provide access to patients with relapsed and refractory disease that have received at least 4 prior regimens and are not eligible for any other enrolling carfilzomib Onyx-sponsored studies enrolling patients in the United States.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically documented multiple myeloma
  2. Age ≥ 18 years
  3. Eastern Cooperative Oncology Group (ECOG) status 0-2.
  4. Life expectancy ≥ 3 months.

  5. 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).

  6. 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.

  7. 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)
    • a corticosteroid
  8. Currently has progressive disease.

  9. Refractory multiple myeloma defined as meeting one or more of the following:

    • Nonresponsive to most recent therapy (eg, stable disease only, or progressive disease while on treatment).
    • Disease progression within 60 days of discontinuation of most recent therapy (most recent therapy must be within 60 days of Screening).
  10. Left ventricular ejection fraction (LVEF) ≥ 40% within 30 days before Cycle 1 Day 1. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation; multi gated acquisition scan (MUGA) is acceptable if ECHO is not available.
  11. Adequate hepatic function, defined as aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) < 3 times the upper limit of normal and serum bilirubin ≤ 2.5 mg/dl.
  12. Absolute neutrophil count ≥ 1,000 (may be supported by growth factors) and platelet count ≥ 40,000 within 14 days before Cycle 1 Day 1 without transfusion.
  13. Creatinine clearance (CrCl) ≥15 mL/minute (measured or calculated using the Cockcroft and Gault Formula) within 14 days before Cycle 1 Day 1. This criterion does not apply to patients on hemodialysis.
  14. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before Cycle 1 Day 1 and must agree to use dual contraception methods for the duration of treatment and for 3 months following the last dose of treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential during the treatment period and for 3 months following the last dose of treatment.
  15. Written informed consent in accordance with federal, local, and institutional guidelines.

Exclusion Criteria:

  1. Prior treatment with carfilzomib or enrollment in any other Phase 3 carfilzomib trial.
  2. Known human immunodeficiency virus (HIV) seropositivity.
  3. Active infection requiring systemic treatment with anti-biotics, anti-virals, or anti-fungals.
  4. Known, active hepatitis A, B, or C viral infection.
  5. 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.
  6. Concomitant use of other investigational agents (eg, anti-biotics or anti-emetics).
  7. Pregnancy or breastfeeding.
  8. History of plasma cell leukemia, defined as > 2.0 × 10ˆ9/L circulating plasma cells.
  9. History of amyloidosis.
  10. Known history of allergy to Captisol®.
  11. 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.
  12. Intolerance to hydration due to pre-existing pulmonary, cardiac, or renal impairment. Patients on hemodialysis should be considered as meeting this criterion for entry.
  13. Waldenström macroglobulemia or immunoglobulin M (IgM) myeloma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Multiple Myeloma Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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