A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple MyelomaMedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000665-36-ES
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 460
*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
consent.
*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
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
disease
? Prostatic intraepithelial neoplasia without evidence of prostate cancer
? Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
situ
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method