Multiple MyelomaNCT01410500
Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease
A study testing Carfilzomib in people with Multiple Myeloma, run by Amgen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Carfilzomib
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Show all 26Show fewer
- 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)
- a corticosteroid
- Currently has progressive disease.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- Written informed consent in accordance with federal, local, and institutional guidelines.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib
- Keywords
- multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
Also called Kyprolis®
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Multiple Myeloma Research Foundation
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410500
- Sponsor's protocol ID
- 2011-002
- Status last verified
- Apr 2017
- First submitted
- 2 Aug 2011
- Last updated
- 2 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease
- ClinicalTrials.gov ID
- NCT01410500
- Acronym / sponsor ID
- 2011-002
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Multiple Myeloma Research Foundation
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarfilzomibAlso: Kyprolis®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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A study testing Carfilzomib in people with Multiple Myeloma, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.