EUCTR2018-000665-36-CZActive, not recruitingPhase 1
A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2) - A.R.R.O.W.2
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Amgen Inc
- Enrollment
- 460
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •*Subject has provided informed consent prior to initiation of any study-specific
- •activities or procedures or subject’s legally acceptable representative has
- •provided informed consent prior to any study-specific activities/procedures being
- •initiated when the subject has any kind of condition that, in the opinion of the
- •Investigator, may compromise the ability of the subject to give written informed
- •*Males or females = 18 years of age.
- •*Documented relapse or progressive multiple myeloma on or after any treatment
- •(subjects refractory to the most recent line of therapy are eligible, unless last
- •treatment contained PI or lenalidomide and dexamethasone).
- •*Subjects must have at least PR to at least 1 line of prior therapy.
- •*Subjects must have received at least 1 but not more than 3 prior lines of therapy
- •for multiple myeloma (induction therapy followed by stem cell transplant and
- •consolidation maintenance therapy will be considered as 1 line of therapy). See
- •Section 12.8 for guidelines for documenting prior treatment.
- •*Prior therapy with a PI or lenalidomide and dexamethasone is allowed, as long
- •as the patient had at least a PR to most recent therapy with PI or lenalidomide
- •and dexamethasone, was not removed due to toxicity, and will have at least a
- •6-month PI or lenalidomide and dexamethasone treatment-free interval from last
- •dose received until first study treatment. (Patients may receive maintenance
- •therapy with lenalidomide during this 6-month PI or lenalidomide and
- •dexamethasone treatment-free interval).
- •*Previous treatment with a lenalidomide and dexamethasone containing regimen
- •is allowed, as long as the subject did not progress during the first 3 months after
- •initiating lenalidomide and dexamethasone containing therapy.
- •Measurable disease with at least 1 of the following assessed within 21 days prior
- •to randomization:
- •? IgG multiple myeloma: serum monoclonal protein (M-protein) level = 1.0 g/dL
- •? IgA, IgD, IgE multiple myeloma: serum M-protein level = 0.5 g/dL
- •? urine M-protein = 200 mg per 24 hours
- •? in subjects without measurable 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 ? 2
- •(see Section 12.9).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
Exclusion Criteria
- •Disease-related
- •*Waldenström macroglobulinemia.
- •*Multiple myeloma of 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).
- •*Primary amyloidosis (patients with multiple myeloma with asymptomatic
- •deposition of amyloid plaques found on biopsy would be eligible if all other
- •criteria are met).
- •*Myelodysplastic syndrome.
- •Other Medical Conditions
- •*History of other malignancy within the past 5 years, with the following exceptions:
- •? Malignancy treated with curative intent and with no known active disease
- •present for = 3 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician
- •? Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease
- •? Adequately treated cervical carcinoma in situ without evidence of disease
- •? Adequately treated breast ductal carcinoma in situ without evidence of
- •? Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •? Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
- •? Treated medullary or papillary thyroid cancer
- •? Similar neoplastic conditions with an expectation of > 95% 5-year
- •disease-free survival
- •*Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve
- •a sustained virologic response after antiviral therapy are allowed), or hepatitis B
- •infection (subjects with hepatitis B surface antigen or core antibody that achieve
- •sustained virologic response with antiviral therapy are allowed). Tests to be
- •performed if required per local country regulations.
- •*Ongoing graft-vs-host disease.
- •*Acute active infection requiring systemic antibiotics, antifungal, antiviral (except
- •antiviral therapy directed at hepatitis B) agents within 14 days prior to
- •randomization.
- •*Known cirrhosis.
- •*Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior
- •to randomization.
- •*Subjects with pleural effusions requiring thoracentesis or ascites requiring
- •paracentesis within 14 days prior to randomization.
- •Cardiopulmonary Conditions
- •*Uncontrolled hypertension, defined as an average systolic blood pressure
- •= 160 mmHg or diastolic = 100 mmHg despite optimal treatment (measured
- •following European Society of Hypertension/European Society of Cardiology
- •2013 guidelines; Section 12.10).
- •*Active congestive heart failure (New York Heart Association Class III to IV),
- •symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected
- •QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction
- •within 4 months prior to randomization.
- •*Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- •*History of interstitial lung disease or ongoing interstitial lung disease.
- +11 more not shown
Investigators
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