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Study Title Principal Investigator
SWOG-S1211: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
PRIMARY OBJECTIVES: I. To determine the appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib, and dexamethasone for patients with multiple myeloma. (Phase I) II. To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high-risk multiple myeloma (HRMM) will improve progression-free survival (PFS). (Phase II) III. To estimate the frequency and severity of toxicities of this treatment strategy in this patient population. (Phase II) OUTLINE: This is a phase I, dose-escalation study of elotuzumab, followed by a phase II, randomized study. PHASE I: INDUCTION: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 6 years.
Recruiting | Blood Cancer | Multisite
Sikander Ailawadhi
16M-14-1: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma
Multiple myeloma is a type of blood cancer caused by the transformation and uncontrolled multiplication of plasma cells (a type pf blood cell). It is the second most common hematological malignancy and is invariably fatal. Myeloma cells expand in the bone marrow causing skeletal destruction, high calcium levels, kidney failure and anemia. The study population will consist of multiple myeloma patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy. The study drug, oprozomib works by preventing the breakdown of certain proteins in cells, causing the cells to die. Studies with oprozomib have been able to demonstrate the treatment potential for blocking proteasomes (protein complexes) in multiple myeloma. These proteasomes main function is to degrade unneeded or damaged proteins. The primary objective of Phase 2 is to estimate the overall response rate. This study is an open-label, Phase 1b/2, multicenter study in which participants will receive oprozomib administered orally, once daily, in combination with dexamethasone as follows: Days 1, 2, 8, and 9 of a 14-day cycle; Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. USC will only participate in Phase 2. The Phase 2 portion of this study will be initiated at the sponsors discretion using the recommended dose determined from 1 or both dosing schedules. The total study duration is expected to be approximately 26 months.
Recruiting | Blood Cancer | Multisite
Kevin Kelly
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A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease
PRIMARY OBJECTIVES: I. To evaluate and compare progression free survival (PFS) of two different doses of carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or refractory disease. SECONDARY OBJECTIVES: I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates (RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high dose carfilzomib. III. To evaluate the safety of this combination for this patient population. IV. To evaluate overall survival (OS). TERTIARY OBJECTIVES: I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow relapse sites. II. To explore the role of positron emission tomography (PET) scanning in assessing disease burden and as a tool to assess treatment response. III. To explore changes in left ventricular ejection fraction (LVEF) in patients with relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose carfilzomib plus dexamethasone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II. ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Note that for the first course of treatment on both arms carfilzomib is given at a reduced rate to assess toxicity. In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years from initial registration.
Recruiting | Blood Cancer | Multisite
Sikander Ailawadhi
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