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- Ensayo clínico NCT02471820
Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients (RAD)
14 de octubre de 2016 actualizado por: Meletios A. Dimopoulos
Phase II Open Label Study for the Assessment of the Efficacy and Safety of Lenalidomide & Adriamycin & Low Dose Dexamethasone (RAD) in Newly Diagnosed, Symptomatic Multiple Myeloma Patients
This study is to assess the efficacy and safety of lenalidomide in combination with adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase II, non randomized, non- comparative, open label trial which assess the efficacy and safety of lenalidomide, adriamycin and low dose dexamethasone combination (RAD) in 45 newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
The recruitment period is estimated for 5 months while the treatment period and the follow up period 4 months and 1 month respectively.
During the treatment initiation visit the response to the combination RAD according the International Myeloma Working Group (IMWG) criteria will be evaluated, biochemical markers of bone metabolism and angiogenic cytokines will be measured as well.
IMWG Response evaluation will be repeated the day 1 of each treatment cycle as well as at the response evaluation visit.
Finally biochemical markers of bone metabolism and angiogenic cytokines will be measured once more at the end of treatment visit.
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Patra, Grecia, 26504
- University General Hospital of Patras
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Thessaloniki, Grecia, 54007
- Theageneio Anticancer Hospital of Thessaloniki
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Attica
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Athens, Attica, Grecia, 11528
- General Hospital of Athens "ALEXANDRA"
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Athens, Attica, Grecia, 11527
- General Hospital of Athens "G. Gennimatas"
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects able to read and understand the Informed Consent Form (ICF).
- Subjects willing to participate in the study and comply with its procedures.
- Subjects who have signed the ICF
- Newly diagnosed patients with symptomatic MM according to the criteria of IMWG
- Subjects eligible for autologous stem cell transplantation
- Age 18-70 years, of either sex
- karnofsky ≥ 60
- Platelets ≥ 100x109/L
- Neutrophils ≥ 1.5x109/L
- Alanine transaminase (ALT) & Aspartate transaminase (AST) ≤ 3-fold of upper normal limit
- Bilirubin ≤ 2-fold of upper normal limit
- Creatinine clearance ≥60 ml/min
- Expected survival ≥ 6 months as per PI's clinical judgment
- Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation
- Female subject of childbearing potential must have 2 negative serum pregnancy tests (hCG) at Screening (once within 10-14 days and once 24 h before the study drug administration) and if sexually active must be using two medically acceptable, highly effective, adequate forms of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and and for time period at least 28 days before the study drug administration and agree to continue using it while being in the study (Screening and Treatment Periods including dose interruptions). A female subject should continue using a highly effective method of birth control for 30 days following the end of treatment.
- A male subject must agree to use an adequate form of contraception for the duration of the study, while taking the study drug, during dose interruptions at for at least 28 days after the last dose of study drug even if he has had a successful vasectomy and agree to have sexual relations only with women who use a highly effective birth control method.
- Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations
Exclusion Criteria:
- Pregnancy, breastfeeding οr intention of pregnancy during the trial
- Suspected or known hypersensitivity to any of the study drugs
- Ongoing severe infection requiring intravenous antibiotic treatment
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the Prostatic specific antigen (PSA) has been stable for 3 years
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Uncontrolled medical problems such as diabetes, coronary artery disease, hypertension, unstable angina, arrhythmia, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to MM
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study
- Subjects with any clinical condition that would affect study's outcome
- Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study, except of the clinical trials that implicate drugs of supportive treatment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Lenalidomide, adriamycin & dexamethasone
Lenalidomide 25 mg administered orally for the first 21 days of each 28-day-cycle, plus Adriamycin i.v. on days 1,2,3 & 4 of every cycle, plus Dexamethasone 40 mg orally on days 1, 8, 15 & 22 of every cycle for 4 cycles
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Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles
Otros nombres:
Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles
Otros nombres:
Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall response rate
Periodo de tiempo: 142 days
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Assessment of the overall response rate of study population to RAD regimen (including stringent complete response, complete response, very good partial response, partial response and stable disease) according to the uniform criteria of IMWG (International Myeloma Working Group) regarding the response to multiple myeloma therapy
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142 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression-free survival (PFS)
Periodo de tiempo: 142 days
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142 days
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Time to progression (TTP)
Periodo de tiempo: 142 days
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142 days
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Time to Next Therapy (TtNT)
Periodo de tiempo: 142 days
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142 days
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Number and severity of Adverse events as a measure of safety and toxicity profile
Periodo de tiempo: 142 days
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Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 2.0)
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142 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT)
Periodo de tiempo: 142 days
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142 days
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Dickkopf-1 (DKK-1)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Dickkopf-1 (DKK-1)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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C-telopeptide of type-I collagen (CTX)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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C-telopeptide of type-I collagen (CTX)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)
Periodo de tiempo: 1 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 days
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Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Bone-alkaline phosphatase (bALP)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Bone-alkaline phosphatase (bALP)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteocalcin (OC)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteocalcin (OC)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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C-terminal propeptide of procollagen type-I (CICP)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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C-terminal propeptide of procollagen type-I (CICP)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Soluble and total RANKL (sRANKL, tRANKL)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Soluble and total RANKL (sRANKL, tRANKL)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteoprotegerin (OPG)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteoprotegerin (OPG)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Osteopontin (OPN)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Osteopontin (OPN)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Macrophage inflammatory protein 1-alpha (MIP-1α)
Periodo de tiempo: 1 day
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Macrophage inflammatory protein 1-alpha (MIP-1α)
Periodo de tiempo: 112 days
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Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Angiopoietin-1 & -2
Periodo de tiempo: 1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Angiopoietin-1 & -2
Periodo de tiempo: 112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Angiogenin
Periodo de tiempo: 1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Angiogenin
Periodo de tiempo: 112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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VEGF
Periodo de tiempo: 1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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Vascular endothelial growth factor (VEGF)
Periodo de tiempo: 112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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VEGF-A
Periodo de tiempo: 1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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VEGF-A
Periodo de tiempo: 112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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basic fibroblast growth factor (bFGF)
Periodo de tiempo: 1 day
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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1 day
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basic fibroblast growth factor (bFGF)
Periodo de tiempo: 112 days
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Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle
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112 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Meletios Dimopoulos, Doctor, General Hospital of Athens "ALEXANDRA"
- Investigador principal: Eirini Katodritou, Doctor, Theageneio Anticancer Hospital of Thessaloniki
- Investigador principal: Nikolaos Anagnostopoulos, Doctor, General Hospital of Athens "G. Gennimatas''
- Investigador principal: Argirios Symeonidis, Doctor, University General Hospital of Patras
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2014
Finalización primaria (Actual)
1 de julio de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2015
Publicado por primera vez (Estimar)
15 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de octubre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
14 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Factores inmunológicos
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Inhibidores de la proteasa
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Antibióticos, Antineoplásicos
- Dexametasona
- Acetato de dexametasona
- BB 1101
- Lenalidomida
- Doxorrubicina
- Doxorrubicina liposomal
Otros números de identificación del estudio
- RV-MM-GMSG-392
- 2011-001499-20 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lenalidomide
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University Hopsital Schleswig Holstein Campus LübeckReclutamientoMieloma múltiple recién diagnosticadoAlemania