800-872-2273

Clinical Trials and Studies

Your participation matters. Help us discover and cure!

Contact us at (800) USC-CARE (800-872-2273)

Study Title Principal Investigator
16M-13-2 A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone versus Bortezomib and Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
Multiple myeloma (MM) is a rare and incurable progressive neoplastic disease that accounts for 10% of all hematological malignancies. the disease follows a relapsing course in the majority of patients, regardless of treatment regimen or initial response totreatment. MM remains incurable using conventional treatments, with median survival duration of approximately 5 years. Therefore, there is a need for more effective therapeutic options for the treatment of relapsed or refractory multiple myeloma. The main considerations for choosing an appropriate treatment for relapsed MM are: risk level, prior therapy, duration of response to prior therapy, residual toxicity, age, physical condition, and whether or not the patient is a candidate for allogeneic stem cell transplantation. Preclinical studies have shown that both thalidomide and lenalidomide potentiate the activity of bortezomib in combination of dexamethasone. This is a multicenter, randomized, open-label study. The principal objective of this study is to compare the efficacy of pomalidomide + bortezomib + low-dose dexamethasone with bortezomib + low-dose dexamethasone in study participants with relapsed or refractory MM. Study participants will be randomized in a 1:1 ratio to Treatment Arm A or B, respectively (Treatment Arm A: (POM + BTZ + LD-DEX) / Treatment Arm B: (BTZ + LD-DEX). All long-term follow-up phase participants will be contacted four (4) times a year (every 3 months) to obtain survival status for at least 5 years after randomization or longer if clinically indicated. PFS will be compared between treatment arms using a log-rank test stratified by the threebaseline factors used in the randomization. The Kaplan-Meier method will be used to estimate the survival distribution functions for each treatment arm. One interim analysis is planned when approximately 50% of the PFS information is reached, i.e., 254 out of the total of 508 PFS events required for the final PFS analysis.
Active, not recruiting | Blood Cancer | Multisite
Ann Mohrbacher
View Research Profile
16M-11-2: A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple Myeloma (MM) Patients to Assess the Relationship between Patient Outcomes, Treatment Regimens and Molecular Profiles
Understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. The promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. However, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. What is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 Therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 The objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. These profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. Ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.
Active, not recruiting | Blood Cancer | Multisite
Sikander Ailawadhi
Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma or Multiple Myeloma
This is a Phase I, open-label, multi-center dose-escalation trial evaluating the safety and tolerability of CUDC-907 as a single agent administered orally, once daily, to patients with relapsed or refractory lymphoma or multiple myeloma. The following dosing schedules may be examined, all consisting of 21-day cycles and including: (i) continuous once daily (QD), (ii) twice weekly on Days 1, 4, 8, 11, 15, 18 (BIW) (iii) thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17, 19 (TIW) (iv) four days on/three days off on Days 1-4, 8-11, and 15-18 (4/3), and (v) five days on/two days off on Days 1-5, 8-12, and 15-19 (5/2) Sequential dose escalation cohorts of oral CUDC-907 are planned. Subject enrollment and dose escalation will proceed according to a standard 3+3 design. In the absence of DLT, each subject will be treated for a minimum of 21 days, and may continue to receive additional treatment until disease progression has been documented or other treatment discontinuation criteria have been met. MTD or BED expansion cohorts of up to 36 evaluable (e.g., up to 12 subjects in each of 2 or 3 specific tumor types or subtype) to better define the safety, tolerability and preliminary antitumor and pharmacodynamic activity of the study treatment, as well as suitability as an RP2D and schedule. Safety and tolerability will be assessed by the incidence and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03). A Safety Review Committee (SRC) comprised of the Medical Monitor, Principal Investigators, and Sponsor representatives, will be convened to review safety information and to decide upon dose escalation and further subject enrollment. The antitumor activity of study treatment will be assessed according to standard response criteria as appropriate for each individual subject's tumor type (e.g., Revised Response Criteria for Malignant Lymphoma and the International Uniform Response Criteria for Multiple Myeloma). Exploratory biological markers of activity will be assessed in peripheral blood mononuclear cells (PBMC), plasma and tissue specimens (skin, tumor and bone marrow samples, where available).
Completed | Lymphoma | Multisite
Kevin Kelly
View Research Profile
A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.
Active, not recruiting | Blood Cancer | Multisite
Kenneth Anderson
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
View Research Profile
S0702, "A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment.
This study is about Zoledronic acid that falls under a category of drugs called bisphosphonates. Bisphosphonates are sometimes given to patients who have cancer that has spread to their bones because it can lower the chances of getting fractures and reduces bone pain. Usually, zoledronic acid is well tolerated by patients, but there has been an increase in the number of reported cases of osteonecrosis of the jaw (ONJ). Symptoms associated with ONJ are swelling of the soft tissue around the jaw, infection, loosening of teeth, drainage, and exposed jaw bone. There is concern about the association of ONJ with bisphosphonate therapy.The primary objective of this study is to prospectively assess, how often ONJ occurs in patients who are being treated with zoledronic acid during a 3 year time period after starting treatment.This is not a treatment study. This study involves collecting information about the treatment with zoledronic acid and collecting information about participants general health and medical history, oral health and dental history and pain assessment through questionnaires.Participants go through some exams, tests or procedures that are part of regular cancer care, like Blood work, Dental exam, Oral x-rays, Medical and dental history, Physical exam.Every six months for up to three years, participants will be asked to provideInformation regarding current treatment for metastatic bone diseaseInformation about any health problems they are havingInformation about their medical history, treatments and physical examInformation regarding their oral health, dental history and exams and pain assessmentIf at any time participants are diagnosed with osteonecrosis of the jaw (ONJ)Every three months for up to three years, they will be asked to provideInformation regarding current treatment for ONJInformation about any health problems they are having with the zoledronic acidInformation regarding oral complications and recent dental proceduresUpdated information on their medical history, physical exam, and treatmentSubmission of dental x-rays and scansThe primary endpoint is the diagnosis of confirmed ONJ. For statistical consideration the goal of this study is to estimate the cumulative incidence rate of confirmed ONJ associated with zoledronic acid at 3 years in patients with bone metastases.About 3,500 people will take part in this study nationally; 200 research participants from USC will take part in this study.
Active, not recruiting | Blood Cancer | Multisite
David Quinn
View Research Profile
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
Powered by SC CTSI