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Latest version submitted June 15, on ClinicalTrials. A study version is represented by a row in the table. Select two study versions to compare. One each from columns A and B. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed.
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Hover over the " Recruitment Status " to see how the study's recruitment status changed. Lothian Maryland tamil sex edits or deletions are displayed in red. Study additions are displayed in green. Scroll up to access the controls. Oversight U. Study Description Brief Summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life HR-QoL and assess the safety of selinexor plus bortezomib Velcade plus low-dose dexamethasone SVd versus bortezomib plus low-dose dexamethasone Vd in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma MM regimens.
Crossover from the Vd Arm to a treatment that includes selinexor i. Detailed Description:. Bortezomib will be given Days 1, 8, 15, and 22 of each day cycle.
Dexamethasone will be given Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each day cycle. Bortezomib will be given Days 1, 4, 8, and 11 of each day cycle for the first 8 cycles. Dexamethasone will be given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each day cycle for the first 8 cycles. Outcome Measures Primary Outcome Measures: 1. Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Documented evidence of progressive MM based on the Investigator's determination according to the modified IMWG response criteria on or after their most recent regimen.
Adequate hepatic function within 28 days prior to C1D1. Adequate renal function within 28 days prior to C1D1. Adequate hematopoietic function within 7 days prior to C1D1. Prior malignancy that required treatment, or has shown evidence of recurrence except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ during the 5 years prior to randomization. Any concurrent medical condition or disease e. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior Lothian Maryland tamil sex C1D1.
Active plasma cell leukemia. Documented systemic light chain amyloidosis. MM involving the central nervous system.
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes POEMS syndrome. Spinal cord compression. Localized radiation to a single site at least 1 week before C1D1 is permitted. Glucocorticoids within 2 weeks of C1D1 are permitted. Patients on long-term glucocorticoids during Screening do not require a washout period but must be able to tolerate the specified dexamethasone dose in this study.
Active graft versus host disease after allogeneic stem cell transplantation at C1D1. Pregnant or breastfeeding females. Major surgery within 4 weeks prior to C1D1. Active, unstable cardiovascular function: Symptomatic ischemia, or Uncontrolled clinically ificant conduction abnormalities e. Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
Contraindication to any of the required concomitant drugs or supportive treatments. Patients unwilling or unable to comply with the protocol, including providing hour urine samples for urine protein electrophoresis at the required time points. Stevens nortonhealthcare. Hamad svha. Janowski calvarymater.
Med Sci jason. Bryson health. Wallington-Beddoe sa. Podar krems. Vlummens uzgent. Lemmens GZA. Venner albertahealthservices. White nshealth. Reece uhn. Sabry saskcancer. Sc anitachandra hotmail. Polyclinic S. Giannopoulos gmail. First I. Pavlov State Medical University of St. Pratt bham.
Cavet christie. Sheehy belfasttrust. Bygrave wales. Scroll up to access the controls Scroll to the Study top. National Library of Medicine U. National Institutes of Health U. April 7, None earliest Version on record 2. May 9, May Lothian Maryland tamil sex, May 25, June 8, November 1, December 31, January 26, February 28, April 5, April 30, June 6, June 29, July 30, August 28, September 30, October 17, May 29, July 31, August 23, September 27, October 31, November 26, February 26, March 31, May 20, August 3, March 2, March 19, June 15, Study Status Record Verification:. FDA-regulated Drug:.
Study Description Brief Summary:. This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life HR-QoL and assess the safety of selinexor plus bortezomib Velcade plus low-dose dexamethasone SVd versus bortezomib plus low-dose dexamethasone Vd in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma MM regimens.
Conditions Conditions:. Study De Study Type:. Drug: Selinexor oral mg dose Drug: Bortezomib subcutaneous dose of 1. Drug: Bortezomib subcutaneous dose of 1. Outcome Measures Primary Outcome Measures:. Eligibility Minimum Age:. Catholic Health Institute St. The Cancer Institute at St.Lothian Maryland tamil sex
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