EUCTR2012-004490-10-BEActive, not recruitingPhase 1
A Multicenter Open label Phase 2 study of Carfilzomib Weekly plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma.
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Ghent University Hospital
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Must be able to understand and voluntarily sign an informed consent form
- •2.Must be able to adhere to the study visit schedule and other protocol requirements
- •3.Age ³ 65 years (at least 65 years of age or older)
- •4.Life expectancy > 6 months.
- •5.Patients must have Symptomatic Measurable previously Untreated MM, as defined below:
- •5.1.Symptomatic MM diagnostic criteria (all 3 required)
- •Monoclonal plasma cells in the bone marrow =10%
- •Monoclonal protein present in the serum and/or urine.
- •Myeloma-related organ dysfunction (at least one of the following)1
- •[C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal)
- •[R] Renal insufficiency (serum creatinine >2 mg/dL)
- •[A] Anemia (hemoglobin <10 g/dL or 2 g < normal)
- •[B] Lytic bone lesions and/or presence of a biopsy-proven plasmacytoma*
- •1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
- •*If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining criteria, then > 30% plasma cells are required in the bone marrow or proven plasmocytic infiltration in bone marrow biopsy
- •5.2.AND have measurable disease as defined by the following: Patients must have a clearly detectable and quantifiable monoclonal M-component value in the serum and/or urine.
- •?IgG (serum M-component > 10g/l)
- •?IgA (serum M-component > 5g/l)
- •?IgD (serum M-component > 0.5g/l)
- •?Light chain (serum M-component >1g/l or Bence Jones > 200mg/24H)
- •?Serum FLC assay: involved FLC level > 10 mg/dl provided serum FLC ratio is abnormal
- •6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •7.Adequate bone marrow function, documented within 72 hours and without transfusion 5 days prior to the first intake of investigational product (C1J1) nor growth factor support, defined as:
- •Absolute neutrophils = 0.75 x109/L,
- •Untransfused Platelet count = 75 x109/L
- •Hemoglobine =8.5 g/L
- •8.Adequate organ function defined as:
- •Serum total bilirubin < 2.0 mg/dL
- •Clairance creatinine = 30ml/min
- •Serum SGOT/AST or SGPT/ALT < 2.5x upper limit of normal (ULN)
- •9.Subjects affiliated with an appropriate social security system.
- •10.Male subjects must:
- •10.1. Understand the potential teratogenic, and genotoxic risk of Melphalan if engaged in sexual activity with a pregnant female or a female of childbearing potential.
- •10.2. Understand the potential genotoxic risk of Carfilzomib if engaged in sexual activity with a pregnant female or a female of childbearing potential.
- •10.3. Practice complete abstinence or understand the need and agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential throughout the entire duration of study treatment, during dose interruptions and until at least 3 months after the end of treatment discontinuation of CMP, even if he has undergone a successful vasectomy. If pregnancy or a positive pregnancy test does occur in the partner of a male study patient during study participation, the investigator must be notified immediately.
- •10.4. Agree not to donate semen or sperm during study drug therapy and until at least 3 months after the end of treatment discontinuation of CMP.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for thi
Exclusion Criteria
- •1.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation.
- •2.Known positive for HIV or active infectious hepatitis, type B or C.
- •3.Patients with non-secretory MM and non-measurable MM
- •4.Patient with terminal renal failure that require dialysis and clairance creatinine < 30 ml/min
- •5.Prior history of malignancies, other than multiple myeloma, unless the patients 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 histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •6.Prior local irradiation within two weeks before first dose
- •7.Evidence of central nervous system (CNS) involvement
- •8.Unable to take corticotherapy at study entry (according to Summary of Cortancyl’s Characteristics)
- •9.Ongoing active infection
- •10.Any ongoing adverse event or medical history > grade 2 severity
- •11.Refusal to participate in the study
- •12.Persons protected by a legal regime (guardianship, trusteeship)
- •13.Alkeran’s (Melphalan) contraindication: Hypersensitivity to Melphalan or to any other constituents.
- •14.Patients with heart failure class 3 and 4 according to the NYHA criteria, or patients with past history of myocardial infarction within the last 6 months or no controlled cardiac conduction abnormalities.
- •15.Patients with a left ventricular ejection fraction under or equal to 30 % (LVEF = 30%).
- •16.Female of childbearing potential (Females are defined as not of childbearing potential if documentation of Natural menopause for at least 24 consecutive months, a hysterectomy, or bilateral oophorectomy”).
Investigators
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