Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) forinduction and consolidation followed by Pomalidomide combined withDexamethason vs Pomalidomide maintenance for patients with MultipleMyeloma in progression after prior 1st line treatment with Lenalidomideand Bortezomib.
- Conditions
- Multiple MyelomaMedDRA version: 19.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003265-34-CZ
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 222
- Included in EMN02/HO95 trial. Induction therapy followed by
autologous stem cell transplant (AutoSCT) and consolidation/
maintenance will be considered as one regimen.
- The subject must understand and voluntarily sign an informed consent
document prior to any study related assessments/procedures.
- Age = 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol
requirements.
- Documented diagnosis of multiple myeloma and measurable disease
(serum M-protein = 10 g/L or urine M-protein = 200 mg/24 hours or
abnormal FLC ratio with involved free light chain (FLC) > 100 mg/L) or
proven plasmacytoma by biopsy).
- Documented progression or refractory multiple myeloma as per the
IMWG uniform response criteria (Durie, 2006) during or after the
EMN02/HO95 trial;
- Normal renal function with a Creatinine Clearance > 45mL/min
according to the Modification of Diet in Renal Disease (MDRD) equation
for estimation of Glomerular Filtration Rate (GFR)
- WHO performance status score of 0, 1 or 2.
- Patients must be willing and capable to use adequate contraception
during the therapy (all men, all pre-menopausal women).
- Patients must be able to adhere to the requirements of the Pregnancy
Prevention Risk Management Plan.
- Patients must be eligible for autologous stem cell transplantation when
not previously given in first line treatment.
- All subjects must agree to refrain from donating blood while on study
drug and for 28 days after discontinuation from this study treatment.
- All subjects must agree not to share medication.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patient received more than 1 regimen (EMN02/HO95), except local
radiotherapy.
- Absolute neutrophil count (ANC) <1.0 x 109/L, unless related to MM.
- Platelet count < 75 x 109/L, unless related to MM.
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or
recombinant human erythropoietin use is permitted).
- Significant hepatic dysfunction (Serum SGOT/AST or SGPT/ALT > 3.0 x
upper limit of normal (ULN) or serum total bilirubin > 3.0 x ULN)
- Prior history of malignancies, other than MM, unless the subject has
been free of the disease for = 5 years. Exceptions include the following:
Basal or squamous cell carcinoma of the skin, carcinoma in situ of the
cervix or breast, Incidental histological finding of prostate cancer (TNM
stage of T1a or T1b).
- Previous therapy with pomalidomide or carfilzomib.
- Hypersensitivity to thalidomide, lenalidomide, bortezomib or
dexamethasone (this includes = Grade 3 rash during prior thalidomide or
lenalidomide or bortezomib therapy).
- Peripheral neuropathy = Grade 2.
- Subjects who received an allogeneic bone marrow or allogeneic
peripheral blood stem cell transplant less than 12 months prior to
initiation of study treatment
- LVEF = 40%.
- QTc > 450 msec.
- History of torsade de pointes.
- History of ventricular tachycardia, ventricular fibrillation.
- Uncontrolled atrial fibrillation/flatter.
- Congestive heart failure (NY Heart Association Class III or IV).
- Myocardial infarction within 12 months prior to starting study
treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal
variant angina pectoris.
- History of pulmonary hypertension.
- Uncontrolled infection.
- Subjects who received any of the following within the last 14 days of
initiation of study treatment:
Major surgery (kyphoplasty is not considered major surgery), use of any
anti-myeloma drug therapy.
- Use of any investigational agents (with the exception of lenalidomide)
within 28 days or five half-lives (whichever is longer) of treatment.
- Incidence of gastrointestinal disease that may significantly alter the
absorption of pomalidomide.
- Subjects unable or unwilling to undergo antithrombotic prophylactic
treatment.
- Any serious medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subjects from signing the informed
consent form.
- Pregnant or breastfeeding females.
- Known human immunodeficiency virus (HIV) positivity, active
infectious hepatitis A, B or C or chronic hepatitis B or C.
- Pre-existing pulmonary, cardiac or renal impairement that prevents
hydration measures as described at section 9.5.
- Any psychological, familial, sociological and geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule.
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