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Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma

Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Bendamustine (Drug); Carfilzomib (Drug); Dexamethasone (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Suzanne Lentzsch, MD

Official(s) and/or principal investigator(s):
Suzanne Lentzsch, MD, PhD, Principal Investigator, Affiliation: Columbia University

Overall contact:
Suzanne Lentzsch, MD, PhD, Phone: 646-317-4840, Email: sl3440@columbia.edu

Summary

This study is a phase I/II study of Carfilzomib in combination with bendamustine and dexamethasone for patients with newly diagnosed Multiple Myeloma.

Clinical Details

Official title: Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose of Carfilzomib in combination with bendamustine and dexamethasone

Secondary outcome:

Overall response rate (ORR)

Duration of response (DOR)

Progression free survival (PFS) Rate

Time to Best Response

Overall survival (OS) Rate

Number of Adverse Events

Number of adverse events in relation to carfilzomib maintenance

Detailed description: This study is a phase I/II study to define dose-limiting toxicity and determine preliminary evidence of efficacy of Carfilzomib in combination with bendamustine and dexamethasone for patients with newly diagnosed Multiple Myeloma. This trial is an open label single-center, dose escalation safety study. A total of up to 34 patients are planned to enroll into the study. Doses will be allocated to patients using a two-stage Up-and-Down dose escalation scheme without intra-patient dose escalation. Patients will receive Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days with dose escalation from 27, 36, 45 to 56 mg/ m2 . No matter what target dose the subject will receive, days 1 and 2 doses in the first cycle will always be 20 mg/m2, followed by target dose for all subsequent dates and cycles. Bendamustine will be given IV on days 1 and 2 with dose escalation up to 90 mg/m2 and dexamethasone 20 mg po or IV on 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. This protocol can also be used as induction therapy for transplant.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age ≥ 18 years 2. Life expectancy ≥ 3 months 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 4. Adequate hepatic function 5. Sufficient Absolute neutrophil count (ANC) within 14 days prior to randomization 6. Sufficient Hemoglobin within 14 days prior to randomization (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines) 7. Sufficient platelet count 14 days prior to randomization 8. Creatinine Clearance ≥ 30 mL/minute within 7 days prior to randomization 9. Left Ventricular Ejection Fraction ≥ 40%. 10. Written informed consent in accordance with federal, local, and institutional guidelines. 11. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. 12. Male subjects must agree to practice contraception. 13. Patients must have histologically or cytologically confirmed symptomatic multiple myeloma (MM). Patients should not have previously been treated. 14. Prior kyphoplasty, vertebroplasty, local radiation therapy for symptomatic bone lesions (e. g., uncontrolled pain or high risk of pathologic fracture) are permitted. 15. Patients are allowed up to two cycles of high dose steroids if needed for symptomatic disease before study enrollment. Exclusion Criteria: 1. Patients who have had chemotherapy for Multiple Myeloma. Exception: local radiation therapy for symptomatic bone lesions (e. g., uncontrolled pain or high risk of pathologic fracture). 2. Patients currently receiving high dose systemic steroids for treatment of Multiple Myeloma in excess of 320mg total dose of dexamethasone or equivalent, patients who received an investigational agent within 5 half-lives of the agent. 3. Patients with non-measurable Multiple Myeloma or primary plasma cell leukemia. 4. Pregnant or lactating females 5. Major surgery within 21 days prior to enrollment 6. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment 7. Known human immunodeficiency virus (HIV) infection 8. Known active hepatitis B or C infection 9. Unstable angina or myocardial infarction within 4 months prior to enrollment 10. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment 11. Uncontrolled, non-hematologic malignancy requiring active treatment. 12. Patients with known brain metastases (treated or not) will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 13. Significant neuropathy within 14 days prior to randomization 14. Known history of allergy to Captisol, or to other agents in the study. 15. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment 16. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment 17. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

Locations and Contacts

Suzanne Lentzsch, MD, PhD, Phone: 646-317-4840, Email: sl3440@columbia.edu

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Suzanne Lentzsch, MD, PhD, Phone: 646-317-4840, Email: sl3440@columbia.edu
Additional Information

Starting date: November 2013
Last updated: August 7, 2015

Page last updated: August 23, 2015

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