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16 studies in Multiple Myeloma

  1. Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma Rochester, MN View Summary
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    Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Determine the safety and toxicity of Edmonston vaccine strain oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma. - Determine the maximum tolerated dose of MV-NIS when administered with or without cyclophosphamide in these patients. Secondary - Determine the time course of viral gene expression and viral elimination, and the biodistribution of virally infected cells at various time points after treatment with these regimens using iodine I 123 gamma camera imaging. - Assess viral replication, viremia, viral shedding in urine and respiratory secretions, and viral persistence after treatment with these regimens. - Monitor humoral responses to MV-NIS in these patients. - Explore the antimyeloma efficacy (i.e., clinical response rate, time to progression, progression-free survival, duration of response) of the virus using standard myeloma response criteria as well as immunoglobulin free light chain measurements. OUTLINE: This is a dose-escalation study of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS). Patients are stratified according to receipt of cyclophosphamide during study treatment (yes vs no). Patients are initially accrued to part 1. Once the maximum tolerated dose (MTD) of MV-NIS alone is determined, subsequent patients are accrued to part 2. - Part 1 (MV-NIS alone [closed to accrual as of 12/17/09]): Patients receive MV-NIS IV over 30 minutes on day 1. Cohorts of 3-6 patients receive escalating doses of MV-NIS until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Part 2 (MV-NIS and cyclophosphamide): Patients receive cyclophosphamide IV over 30 minutes on day -1 and MV-NIS IV over 30 minutes on day 1. Cohorts of 3-6 patients receive escalating doses of MV-NIS* in combination with cyclophosphamide until the MTD is determined. The MTD of MV-NIS is defined as in part 1. NOTE: *Starting dose of MV-NIS is the MTD determined in part 1. Blood and bone marrow samples are obtained for research studies, including flow cytometry, at baseline and at week 6. Serial measurements of viral RNA in mononuclear cells are conducted in samples of blood, saliva, and urine on days 3, 8, and 15 and are tested for viral replication by quantitative reverse transcriptase-polymerase chain reaction. Measles virus-specific immunity is evaluated at baseline and on day 42. After the completion of study treatment, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

    NCT ID:

    NCT00450814

    IRB Number:

    06-005263

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        


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  2. Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction

    Location:

    Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment. OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]). Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity. Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only). After completion of study treatment, patients are followed every 6 months for up to 3 years.

    NCT ID:

    NCT00790842

    IRB Number:

    08-003156 11-002048

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  3. Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma Rochester, MN View Summary
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    Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) of LBH589 and RAD001 when used in combination in patients with myeloma or lymphoma (Phase I). II. Arm A: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory lymphoma. (Phase II) III. Arm B: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory multiple myeloma (Phase II) SECONDARY OBJECTIVES: I. To further describe the toxicities associated with the combination of LBH589 with RAD001 in each arm independently. II. To evaluate overall survival, progression-free survival, and duration of response in each arm independently. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetic interaction of LBH589 and RAD001. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat and oral everolimus once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed periodically for 2 years.

    NCT ID:

    NCT00918333

    IRB Number:

    08-004746

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        


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  4. Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

    Location:

    Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) with the combination of MLN8237 and bortezomib. (Phase I) II. To describe the toxicities associated with the combination of MLN8237 and bortezomib. (Phase I) III. To evaluate the overall response rate to the combination of MLN8237 and bortezomib in patients with relapsed or refractory multiple myeloma. (Phase II) SECONDARY OBJECTIVE: I. To assess progression-free and overall survival in patients treated with this combination. (Phase II) OUTLINE: This is a phase I dose escalation study followed by a phase II study. Patients receive oral aurora kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment all patients are followed every 2 months for 1 year and then every 3 months for 1 year.

    NCT ID:

    NCT01034553

    IRB Number:

    08-006317

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  5. Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma

    Location:

    Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II) SECONDARY OBJECTIVES: I. Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen. III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy. OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study. Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.

    NCT ID:

    NCT01057225

    IRB Number:

    09-004091

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  6. Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

    Location:

    Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Study the risk of grade 3-4 non-hematologic adverse events in patients with asymptomatic high-risk smoldering multiple myeloma treated with lenalidomide. (Phase II) II. Compare the progression-free survival (PFS) of patients with asymptomatic high-risk smoldering multiple myeloma treated with lenalidomide versus observation alone. (Phase III) SECONDARY OBJECTIVES: I. Assess the response of patients treated with lenalidomide. (Phase II) II. Determine and compare the response rate, time to progression, 1-year PFS probability, and the overall survival of patients treated with lenalidomide versus observation alone. (Phase III) III. Estimate the incidence of adverse events of these regimens in these patients. (Phase III) TERTIARY OBJECTIVES: I. Describe the cohort in terms of GEP and cytogenetic risk classification and evaluate baseline immune and MRI parameters. (Phase II) II. Evaluate the impact of therapy within GEP-defined risk groups and GEP as a prognostic marker. (Phase III) III. Study the effects of lenalidomide on laboratory markers of immune function. (Phase III) IV. Study the prognostic value of MRI-detected asymptomatic bone disease on clinical outcome. (Phase III V. Evaluate the prognostic effect of baseline high-risk cytogenetic abnormalities on clinical outcome. (Phase III) QUATERNARY OBJECTIVES: I. To compare QOL change between treatment and observation arms based on the functional (FWB) and physical (PWB) well-being components of the FACT-General (G) patient-reported outcome (PRO) measure from registration (prior to initiation of treatment) up to cycle 24. II. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT FWB+PWB up to cycle 48. III. To obtain prospective data on Myeloma specific QOL attributes, utilizing and evaluating the Multiple Myeloma Subscale (MMS). OUTLINE: This is a multicenter study. PHASE II: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. PHASE III: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard of care and undergo observation in the absence of disease progression. Peripheral blood, bone marrow aspirate, and bone marrow core biopsy samples are collected for gene expression profiling, immune function, and cytogenetic abnormalities. Patients complete the Functional Assessment of Cancer Therapy (FACT) Physical Well-Being (PWB), and FACT Functional Well-Being (FWB) questionnaires at baseline and periodically during study. After completion of study therapy, patients are followed up periodically for 10 years.

    NCT ID:

    NCT01169337

    IRB Number:

    10-007153

    Who can I contact for additional information about this study?

    Rochester: John A. Lust 507-538-7623
                        
    Scottsdale: John A. Lust 507-538-7623
                        

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  7. Safety and Tolerability Study of SNS01-T in Relapsed or Refractory Multiple Myeloma, Mantle Cell Lymphoma, or Diffuse Large B Cell Lymphoma Rochester, MN View Summary
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    Safety and Tolerability Study of SNS01-T in Relapsed or Refractory Multiple Myeloma, Mantle Cell Lymphoma, or Diffuse Large B Cell Lymphoma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, mantle cell lymphoma and diffuse large B cell lymphoma.

    NCT ID:

    NCT01435720

    IRB Number:

    11-002766

    Who can I contact for additional information about this study?

    Rochester: John A Lust, MD 507-266-2040
                        


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  8. Proteasome Inhibitor MLN9708 in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Proteasome Inhibitor MLN9708 in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the confirmed overall response rate (>= partial response [PR]) of MLN9708 (proteasome inhibitor MLN9708), used as a single agent in patients with relapsed multiple myeloma, who are proteasome inhibitor naive (including bortezomib) naive OR have received less than 6 cycles of therapy with bortezomib and had a better than PR with no progression at the time of discontinuation. SECONDARY OBJECTIVES: I. To determine the overall response rate of MLN9708 in combination with dexamethasone, when dexamethasone is added to MLN9708 for lack of response or for progression. II. To determine the event free survival and overall survival among patients with relapsed myeloma following treatment with MLN9708 with dexamethasone added for lack of response or progression. OUTLINE: Patients receive MLN9708 orally (PO) on days 1, 8 and 15. Patients with lack of minor response by the end of the second course or lack of partial response by the end of the fourth course also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 or 12 months for 2 years.

    NCT ID:

    NCT01415882

    IRB Number:

    11-001516

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Jacksonville: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  9. Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone. II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma. SECONDARY OBJECTIVES: I. Time to progression. II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population. OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

    NCT ID:

    NCT01212952

    IRB Number:

    10-001545

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Jacksonville: Mayo Clinic Clinical Trials Office 507-538-7623
                        

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  10. A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma Rochester, MN View Summary
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    A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).

    NCT ID:

    NCT01456689

    IRB Number:

    11-007884

    Who can I contact for additional information about this study?

    Rochester: Susan Wescott
                        


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