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Complete title: A Multi-Center Phase 1b, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide with Dexamethasone Prior to Autologous Stem Cell Transplant in Patients with Transplant Eligible Newly Diagnosed Multiple Myeloma
|Research Study Number||2599.00|
|Principal Investigator||Bill Bensinger, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Cytopathologically or histologically confirmed diagnosis of MM
- Measurable disease, as indicated by one or more of the following:
- Serum M-protein = or> 1.0 g/dL
- Urine Bence Jones protein = or> 200 mg/24 hr
- Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria
- Males and females = or> 18 years of age
- Life expectancy of more than 5 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.5 times ULN
- Serum Creatinine Clearance(CrCl) = or> 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
- Additional Laboratory Requirements
- Absolute neutrophil count (ANC) = or>1.0 x 109/L
- Hemoglobin = or> 8 g/dL [transfusion permitted]
- Platelet count = or> 50.0 x 109/L
- Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
- Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
- Written informed consent in accordance with federal, local, and institutional guidelines
- Patients must agree to practice contraception
- Male patients must agree not to donate semen or sperm.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving = or > 1/3 of the pelvic area is also allowed)
- Plasma cell leukemia
- Pregnant or lactating females
- Major surgery within 21 days prior to first dose
- Congestive heart failure (CHF) (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
- Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
- Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
- Serious psychiatric or medical conditions that could interfere with treatment
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
- Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone = or> 1.5 mg/day or prednisone = or> 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
- Patients in whom the required program of oral and IV fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
- Patients with primary systemic amyloidosis.
Other exclusion criteria may apply.
Multiple Myeloma (MM)
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