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  • Belimumab With Rituximab for Primary Membranous Nephropathy

    This trial is a two-part study (Part A and Part B) of adults with primary membranous nephropathy (MN), ages 18-75 inclusive. The study will be conducted at multiple sites in the United States and Canada. Part A: Open-label Phase Part A is an open-label, PK study to compare belimumab exposure between participants who have "low" proteinuria (≥ 4 to < 8 g/day) and "high" proteinuria (≥ 8 g/day) at Visit -1. Initially Part A planned to enroll 20 individuals with primary MN: 10 individuals with low proteinuria and 10 individuals with high proteinuria. All Part A participants received 200 mg subcutaneous belimumab weekly, the initially approved dose of belimumab in SLE, for 52 doses (weeks 0-51). Trough serum belimumab levels would be obtained weekly following the first 4 doses of belimumab. All participants would receive rituximab 1000 mg IV at weeks 4 and 6, and are followed after the 52 week treatment period on no study medication until week 156. Belimumab trough levels were to be analyzed after all 20 participants received the first 4 doses to compare the belimumab exposure between the low and high proteinuria groups. If the belimumab exposure was not comparable between the high and low proteinuria groups, the belimumab dose would be doubled to 400 mg/weekly for participants with high proteinuria in Part B. Dose determination for participants with high proteinuria in Part B would be made by an adjudication committee comprised of the Protocol Chair, NIAID Medical Monitor, ITN Clinical Trial Physician, and Rho Scientist, in consultation with the belimumab PK expert at GSK. Due in part to the observed imbalance in enrollment between the high and low proteinuria groups, an ad hoc PK analysis was conducted. The serum belimumab trough levels of the first 12 participants (8 with high proteinuria and 4 with low proteinuria) who received the first 4 belimumab doses were analyzed to compare belimumab exposure between the low and high proteinuria groups. The results of the PK analysis were reviewed by the adjudication committee, who determined that the results did not support doubling the dose of belimumab in individuals with high proteinuria nor did it identify a new proteinuria threshold that warranted an increased belimumab dose. The belimumab PK expert at GSK concurred. Thus, enrollment into Part A has been suspended, and all participants in Part B are to receive the same dose of belimumab. All participants currently enrolled in Part A continue to receive belimumab and rituximab as previously planned and are undergoing the safety assessments as presented in Appendix A. All enrolled participants in Part A will be followed until week 156 and will be assessed for the same study endpoints as participants in Part B. Part B: Randomized Phase Part B is a prospective, randomized, phase II, double-blind, placebo-controlled, multicenter clinical trial in adults with primary MN to assess the effectiveness of belimumab and rituximab at treating primary MN. Part B is commencing after the completion of the ad hoc PK analysis, which did not support increasing the belimumab dose in participants with high proteinuria. A total of 58 participants will be randomized into two treatment arms. Randomization will be stratified by low (≥ 4 to < 8 g/day) and high proteinuria (≥ 8 g/day). Eleven participants who entered Part B prior to protocol version 7.0 were randomized at a 1:1 ratio; 47 participants entering at or after protocol version 7.0 will be randomized at a 3:1 ratio. A total of 41 participants are projected to be enrolled in the belimumab and rituximab arm and 17 participants in the belimumab placebo and rituximab arm. The effectiveness of belimumab with rituximab will be evaluated using a hybrid control arm that combines participants who receive belimumab placebo and rituximab in this study and the subgroup of subjects with primary MN in the MENTOR trial who were anti-PLA2R positive at baseline and received rituximab alone. The randomized arms will also be used to evaluate the safety of adding belimumab to rituximab in primary MN and to support mechanistic studies. Participants randomized to the belimumab and rituximab arm will receive subcutaneous belimumab 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. This dosing regimen is based on the recommended dosing of subcutaneous belimumab for lupus nephritis. Participants randomized to the belimumab placebo and rituximab arm will receive subcutaneous belimumab placebo according to the same dose and schedule. Participants in both arms will receive rituximab 1000 mg IV at weeks 4 and 6. At week 30, participants will be assessed for a response to study treatment. Participants who meet at least two of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and, defined as fulfilling at least two of the following three criteria at week 30, will receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36): - Anti-PLA2R levels is ≥ 25% of baseline - Proteinuria is ≥ 50% of baseline - Serum albumin is < 2.8 g/dL After the 52 week treatment period, all participants will be followed on no study medication with assessment of the primary endpoint (CR or PR) at week 104. The primary endpoint will be assessed at week 104 because the proteinuric response to treatment is known to lag behind the active treatment period and is recommended to be assessed at least 18 months after the initiation of therapy. There will be a tolerance endpoint at week 156 to determine if treatment with belimumab with rituximab results in a more durable remission compared to rituximab alone, and to assess the rate of relapse after having achieved complete or partial remission.

    Phase

    2

    Span

    521 weeks

    Sponsor

    National Institute of Allergy and Infectious Diseases (NIAID)

    Duluth, Georgia

    Recruiting

  • S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

    PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. II. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction. V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons. TERTIARY OBJECTIVES: I. To evaluate the isoleucine (lle) 655 valine (Val) and and alanine (Ala)ll70 proline (Pro) single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction. II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker of study-defined cardiac dysfunction. III. To evaluate the feasibility of performing serial left ventricular strain in a National Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing both a baseline and at least one follow-up strain measurement. IV. To bank blood for future translational medicine studies such as brain natriuretic peptide (BNP), additional SNPs, and high sensitivity troponin. OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE inhibitor at registration are assigned to Arm III. ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol orally (PO) twice daily (BID). Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks. ARM III: Patients undergo observation for up to 108 weeks. After completion of study, patients are followed up for up to 108 weeks.

    Phase

    3

    Span

    515 weeks

    Sponsor

    SWOG Cancer Research Network

    Duluth, Minnesota

    Recruiting

  • Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

    PRIMARY OBJECTIVES: I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors, and at least 95% for patients with ovarian pure immature teratoma. II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors. IIa. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin [C] etoposide [E] bleomycin [b]) vs. a cisplatin-based regimen (cisplatin [P]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT). IIb. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - < 25 years) with standard risk GCT. SECONDARY OBJECTIVES: I. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors. EXPLORATORY OBJECTIVES: I. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein [FP] and beta-human chorionic gonadotropin [HCG]) with clinical outcome in low and standard risk germ cell tumor patients. II. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. III. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS) instrument. IV. To evaluate the prognostic significance of serum micro ribonucleic acid (miRNA)s in stage I testicular cancer (seminoma and non-seminoma) patients by collecting clinical data and serum specimens for future analysis. OUTLINE: Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma malignant germ cell tumors (MGCT)s undergo observation and can transfer to standard risk arm at time of recurrence if eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-ray as well as blood sample collection throughout the trial to monitor for response and recurrence. Patients may also undergo a tumor biopsy throughout the trial. Patients with standard risk 1 are randomized into 1 of 2 arms. ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. Patients with standard risk 2 are randomized into 1 of 2 arms. ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. After completion of study treatment, patients are followed up every 2 months for 12 months, every 3-6 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

    Phase

    3

    Span

    527 weeks

    Sponsor

    Children's Oncology Group

    Duluth, Minnesota

    Recruiting

  • Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

    PRIMARY OBJECTIVE: I. To determine the extent of clinical benefit of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+, exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Patient reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal tissue parameters. VII. Concordance measurements of central versus parent-institution pathology. VIII. Assessment of pHH3 mitotic index and its correlation with progression-free survival (PFS) and OS. IX. Validation of the prognostic value of a 34-gene expression biomarker. X. Validation of the predictive value of a 34-gene expression biomarker in predicting the benefit of radiotherapy. XI. Tissue and specimen collection for future translational research. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo observation. Additionally, patients undergo magnetic resonance imaging (MRI) and blood collection throughout the study. ARM II: Patients undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study. After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6 months for year 2 and 3, then yearly for 10 years.

    Phase

    3

    Span

    509 weeks

    Sponsor

    NRG Oncology

    Duluth, Minnesota

    Recruiting

  • Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

    PRIMARY OBJECTIVE: I. Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer compared to NADT and high-dose prostate and seminal vesicle (SV) radiation therapy (prostate [P] + SV radiation therapy [RT]) using intensity-modulated radiotherapy (IMRT) or external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost. SECONDARY OBJECTIVES: I. Demonstrate that prophylactic WPRT improves biochemical control. II. Distant metastasis (DM)-free survival. III. Cause-specific survival (CSS). IV. Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT + P and SV RT. V. Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT). (closed to patient accrual 3/9/15) VI. Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (Patient-Reported Outcome Measurement Information System [PROMIS] Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (interleukin [IL]-1, IL-1 receptor antagonist [ra], IL-6, tumor necrosis factor [TNF]-alpha, and C-reactive protein). (closed to patient accrual 3/9/15) VII. Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). (closed to patient accrual 3/9/15) VIII. Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points. IX. Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses. OUTLINE: Patients are randomized to 1 of 2 treatment arms. All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily (QD) or flutamide PO thrice daily (TID) for 6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 6 or 32 months. Radiotherapy begins within 8-10 weeks after beginning LHRH agonist/antagonist injection. ARM I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using IMRT* or 3D-conformal radiation therapy (3D-CRT)* QD, 5 days a week, for approximately 9 weeks. Patients may also undergo PPI brachytherapy or high-dose rate brachytherapy (iodine I 125 or palladium Pd 103 may be used as the radioisotope). ARM II: Patients undergo WPRT* (3D-CRT or IMRT) QD, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in Arm I. NOTE: * Patients undergoing brachytherapy implant receive 5 weeks of IMRT, 3D-CRT, or WPRT. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

    Phase

    3

    Span

    Sponsor

    Radiation Therapy Oncology Group

    Duluth, Minnesota

    Recruiting

  • MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

    In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

    Phase

    N/A

    Span

    512 weeks

    Sponsor

    Vertos Medical, Inc.

    Duluth, Minnesota

    Recruiting

  • Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

    PRIMARY OBJECTIVES: I. To determine the 3-year event free survival, defined as the proportion of patients without invasive or metastatic recurrence following definitive gemcitabine hydrochloride (gemcitabine) and cisplatin (standard or dose-dense) chemotherapy in those patients whose pre-treatment transurethral resection of bladder tumor (TURBT) tumors harbor deleterious DDR gene alterations and who achieve < cT1 response to chemotherapy. SECONDARY OBJECTIVES: I. To determine the clinical response rate (< cT1) for patients harboring deleterious DDR gene alterations following dose dense gemcitabine and cisplatin. II. To determine the bladder-intact and overall survival for DDR-altered patients with < cT1. III. For DDR gene altered patients who elect radical cystectomy despite < cT1, to determine the pT0 rate in this patient population. IV. To determine the pathologic response rate at cystectomy and 3-year recurrence-free and overall survival for patients without DDR mutations who are registered onto this trial. V. To assess the local treatment burden (Bacillus Calmette-Guerin [BCG] therapy, resection of non-invasive disease, checkpoint blockade) over time in the bladder-sparing group. VI. To determine the bladder-intact disease-free survival in patients who elect to undergo chemoradiation therapy in the DDR mutant group and the DDR wild-type group. OUTLINE: Participants receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim subcutaneously (SC) on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants are then assigned to 1 of 2 arms. ARM I: Participants with DDR gene alteration and disease stage < cT1 undergo bladder sparing. ARM II: Participants with DDR gene alteration and disease stage >= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy. After completion of study treatment, participants are followed up for 5 years.

    Phase

    2

    Span

    530 weeks

    Sponsor

    Alliance for Clinical Trials in Oncology

    Duluth, Minnesota

    Recruiting

  • Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

    PRIMARY OBJECTIVES: I. To evaluate the disease-free survival (DFS) of patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) and disruptive p53 mutations after primary surgical resection followed by postoperative radiotherapy (PORT) alone or PORT with concurrent cisplatin. SECONDARY OBJECTIVES: I. To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. II. To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. III. To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. IV. To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin. V. To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo IMRT QD 5 days a week and receive cisplatin intravenously (IV) over 1-2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years and then every 12 months for 7 years.

    Phase

    2

    Span

    580 weeks

    Sponsor

    ECOG-ACRIN Cancer Research Group

    Duluth, Minnesota

    Recruiting

  • Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

    PRIMARY OBJECTIVES: I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB >= 4 cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection. SECONDARY OBJECTIVES: I. To evaluate and compare disease-free survival (DFS) associated with crizotinib. II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting. III. To collect tumor tissue and blood specimens for future research. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo observation. After completion of study treatment, patients are followed up every 6 months if < 4 or 5 years from study entry, and every 12 months if 5-10 or 6-10 years from study entry.

    Phase

    3

    Span

    1102 weeks

    Sponsor

    ECOG-ACRIN Cancer Research Group

    Duluth, Minnesota

    Recruiting

  • Connect® Myeloid Disease Registry

    This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease will be recorded, including initial treatment and any subsequent therapy. Data on treatment outcomes, including response rates as measured by the treating physician, evidence of progression, survival, and patient-reported outcomes will be collected quarterly on the electronic CRF.

    Phase

    N/A

    Span

    903 weeks

    Sponsor

    Celgene

    Duluth, Minnesota

    Recruiting

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