Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
Conditions
This trial is treating people with Multiple Myeloma
Eligibility
Inclusion
- Relapsed multiple myeloma
-
Refractory multiple myeloma defined as meeting 1 or more of the following:
- Nonresponsive to most recent therapy (stable disease only or PD while on treatment), or
- Disease progression within 60 days of discontinuation from most recent therapy
- At least 2 but no more than 3 prior therapies for multiple myeloma
- Prior exposure to an immunomodulatory agent (IMiD)
- Prior exposure to a proteasome inhibitor (PI)
- Documented response of at least partial response (PR) to 1 line of prior therapy
-
Measurable disease with at least 1 of the following assessed within the 21 days prior to randomization:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Left ventricular ejection fraction (LVEF) ≥ 40% within the 21 days prior to randomization
-
Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
- Bilirubin < 1.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
- Absolute neutrophil count (ANC) ≥ 1000/mm³ (screening ANC should be independent of growth factor support for ≥ 1 week)
- Hemoglobin ≥ 8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
- Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%. Subjects should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.)
- Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/min
Exclusion
- Waldenström macroglobulinemia
- Multiple myeloma of Immunoglobin M (IgM) subtype
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 × 10⁹/L circulating plasma cells by standard differential)
- Myelodysplastic syndrome
-
Second malignancy within the past 5 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
- Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- Treated medullary or papillary thyroid cancer
- Similar condition with an expectation of > 95% five-year disease-free survival
- History of or current amyloidosis
- Cytotoxic chemotherapy within the 28 days prior to randomization
- Immunotherapy within the 21 days prior to randomization
- Glucocorticoid therapy within the 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or 1000 mg prednisone
-
Radiation therapy:
- Focal therapy within the 7 days prior to randomization
- Extended field therapy within the 21 days prior to randomization
- Prior treatment with either carfilzomib or oprozomib
- Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
- Contraindication to dexamethasone or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to enrollment
- Active infection within the 14 days prior to randomization requiring systemic antibiotics
- Pleural effusions requiring thoracentesis within the 14 days prior to randomization
- Ascites requiring paracentesis within the 14 days prior to randomization
- Ongoing graft-versus-host disease
- Uncontrolled hypertension or uncontrolled diabetes despite medication
- Significant neuropathy (≥ Grade 3) within the 14 days prior to randomization
- Known cirrhosis
Inclusion
- You have had a certain type of treatment or surgical procedure.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AMGEN
Scientific Title
A Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information