A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma
This phase 3 clinical trial will compare the progression-free survival of relapsed multiple myeloma patients receiving carfilzomib, lenalidomide, and dexamethasone (CRd) versus lenalidomide and dexamethasone (Rd) alone. Approximately 700 patients will be randomized 1:1 to receive CRd for 12 cycles then CRd without carfilzomib, or Rd alone. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, response rates, safety, and time to progression or next treatment.
Результаты исследования ЕБРР «Реализация инвестиционного потенциала распределённой генерации в России», Быкова Ольга, Branan, директор, руководитель практики «Стратегия». Практический семинар «Распределённая генерация: правовые аспекты и примеры проектов», 21 июня 2013 г.
Con la consapevolezza della grande risorsa rappresentata dalla Tecnologia Informatica vogliamo mettere a fattore comune attività e conoscenze di Professionisti , Aziende ICT e Associazioni per contribuire allo Sviluppo Sociale ed accrescere l’attenzione ai temi legati all’Etica, alla Sostenibilità e alla Solidarietà.
Check Valves at the reasonable prices are available at Just Water Stuff. Please visit the link http://www.justwaterstuff.com and explore the lists of other water products.
V b одд. ОУ Свети Климент Охридски-Бутел, Скопје одд. наставник Сузана Младенова (изработки од моите ученици). Примена на ИКТ во секојдневни активности на часот, домашни задачи, проектни активности.
Proactive Approaches for Building a Professional NetworkDonna Kridelbaugh
Slides from a webinar that I presented for the Association for Women in Science in November 2012. The objectives of the webinar were to 1) provide an overview of various environments to meet other people; 2) outline several proactive techniques on how to target and approach contacts of interest; and 3) offer suggestions on how to ensure the setup of a networking event will be successful.
Ashcan Studio of Art: Art School Admissions Ashcan Studio
Ashcan Studio of Art Inc. is the leading art and design portfolio preparation school in New York. We offer Portfolio Preparation Programs, Visual Arts and Youth Art courses to the local, national and international community.
We assist all aspiring students, regardless of their experience level in the visual arts, gain entrance into the country’s top art programs.
We offer courses in Portfolio Preparation which include Drawing, Painting, Sculpture, Figure Studies, Film/Animation, Fashion Illustration, Fashion Design and Garment Construction.
Visual Arts education has been our field of focus since 2006. We are committed to cultivating within our students the curiosity to explore creative intellect and aesthetics. Our students enjoy small class sizes taught by Instructors whose commitment to teaching and scholarship is remarkable.
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Ashcan Studio of Art has established an excellent reputation at colleges and universities for the preeminence of portfolios submitted to them by our students. These students have been accepted to major visual arts schools and they have been offered extraordinary amounts of merit-based scholarships.
In addition we have beneficially partnered with The School of Visual Arts in the form of a 1 + 3 agreement, through which our students can earn transferable credit hours at our studio. As well as The Joan Mitchell Foundation, which funds scholarships for students in the community to study with us.
Similar to A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma
Chair & Presenter, Robert Z. Orlowski, MD, PhD, Noa Biran, MD, and Ajay K. Nooka, MD, MPH, FACP, prepared useful Practice Aids pertaining to multiple myeloma for this CME/MOC/AAPA activity titled “The New ABCs of Myeloma Care: Enhancing Outcomes With CD38 Antibodies, BCMA Immunotherapy, and Unique Bispecific Platforms.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at https://bit.ly/3MPq140. CME/MOC/AAPA credit will be available until July 3, 2024.
Luciano J. Costa, MD, PhD, prepared useful Practice Aids pertaining to multiple myeloma for this CME activity titled "Exploring Clinical Decisions in the New Era of Myeloma Management: The Impact of Novel Platforms and Agent Classes Across the Spectrum of Care." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2Dypn7b. CME credit will be available until March 12, 2020.
Recent advancements in metastatic colorectal cancer treatmentKindai University
In this presentation, the presenter tries to provide an overview of the current established treatment strategies, based on their clinical outcomes as well as their mechanisms, limitations that remain to be overcome, and their future applicability for the treatment of human Colorectal Cancer.
Apalutamide in metastatic castration resistant prostate cancerGaurav Kumar
TITAN trial
journal club
apalutamide
prostate cancer
metastatic castration resistant prostate cancer
CRPC
androgen receptor blocker
Similar to A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma (20)
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma
1. A Randomized, Multicenter,
Phase 3 Study Comparing
Carfilzomib, Lenalidomide, and
Dexamethasone (CRd) vs
Lenalidomide and
Dexamethasone (Rd) in Subjects
with Relapsed Multiple Myeloma
Michael Wang, M.D.
Associate Professor
Department of Lymphoma and Myeloma
M. D. Anderson Cancer Center
20. A Randomized, Multicenter,
Phase 3 Study Comparing
Carfilzomib, Lenalidomide, and
Dexamethasone (CRd) vs
Lenalidomide and
Dexamethasone (Rd) in Subjects
with Relapsed Multiple Myeloma
Michael Wang, M.D.
Associate Professor
Department of Lymphoma and Myeloma
M. D. Anderson Cancer Center
21. To compare progression-free survival in subjects with
relapsed multiple myeloma who are receiving CRd vs
subjects receiving Rd alone in a randomized
multicenter setting.
PRIMARY OBJECTIVES
22. Phase 3, randomized, open-label, multicenter study
comparing two treatment regimens for subjects with
relapsed multiple myeloma.
Subjects will be randomized in a 1:1 ratio to
receive either the control Rd or CRd.
Randomization will be stratified by β2 microglobulin levels
(< vs ≥ 2.5 mg/L), prior bortezomib (no vs
yes), and prior lenalidomide (no vs yes).
Estimated sample size is 700 subjects and will take place
at approximately 200 centers.
Primary endpoint is progression-free survival.
STUDY DESIGN
23. Subjects will receive the treatment determined by
randomization in 28-day cycles until disease
progression or unacceptable toxicity.
Subjects will be followed for 30 additional days after
completion or early discontinuation of treatment for
safety follow-up.
Long-term follow-up for disease status and survival
will continue until the subject has withdrawn consent
for further participation, is lost to follow-up, has died,
or the Sponsor makes a decision to close the study.
STUDY DESIGN Continued
24. Symptomatic multiple myeloma with measurable disease, as defined by
one or both of the following (assessed within 14 days prior to
randomization):
• Serum M-protein ≥ 0.5 g/dL
• Urine Bence-Jones protein ≥ 200 mg/24 hours
Prior treatment with at least one, but no more than three, regimens for
multiple myeloma
Documented relapse or progressive disease on or after any regimen
(subjects refractory to the most recent line of therapy are eligible)
Achieved a response to at least one prior regimen (defined as
≥ 25% decrease in M-protein
Age ≥ 18 years and Life expectancy ≥ 3 months
Eligibility Criteria - Inclusion
25. • Eastern Cooperative Oncology Group performance status 0–2
• Adequate hepatic function, with serum ALT ≤ 3.5 times the upper
limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 μmol/L)
within 14 days prior to randomization
• Absolute neutrophil count ≥ 1.0 × 109/L within 14 days prior to
randomization
•Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to
randomization (subjects may be receiving red blood cell
transfusions in accordance with institutional guidelines)
• Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if myeloma involvement
in the bone marrow is > 50%) within 14 days prior to
randomization
• Creatinine clearance (CrCl) ≥ 50 mL/minute (either measured or
calculated using a standard formula such as Cockcroft and Gault)
within 7 days prior to randomization
Eligibility Criteria - Inclusion
26. • Written informed consent in accordance with federal, local, and
institutional guidelines
• Females of childbearing potential must agree to ongoing
pregnancy testing and to practice contraception as outlined
• Male subjects must agree to practice contraception as outlined
Eligibility Criteria - Inclusion
27. 1. If previously treated with bortezomib (alone or in combination),
progression during treatment
2. If previously treated with a lenalidomide and dexamethasone
(len/dex) combination:
• Progression during the first 3 months of initiating treatment
• Any progression during treatment if the len/dex regimen was the
subject’s most recent line of therapy
3. Discontinuation of previous lenalidomide or dexamethasone due
to intolerance; subjects who are intolerant to bortezomib are not
excluded
4. Prior carfilzomib treatment
5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy,
monoclonal protein, and skin changes)
6. Waldenström’s macroglobulinemia or IgM myeloma
7. Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by
standard differential)
8. Chemotherapy (approved or investigational) within 3 weeks prior
to randomization or antibody therapy within 6 weeks prior to
randomization
Eligibility Criteria - Exclusion
28. 9. Radiotherapy to multiple sites or immunotherapy/antibody therapy
within 28 days prior to randomization; localized radiotherapy to a
single site within 7 days prior to randomization
10. Corticosteroid therapy at dose equivalent to dexamethasone
> 4 mg/day within 21 days prior to randomization
11. Pregnant or lactating females
12. Major surgery within 21 days prior to randomization
13. Acute active infection requiring treatment (systemic antibiotics,
antivirals, or antifungals) within 14 days prior to randomization
14. Known human immunodeficiency virus infection
15. Active hepatitis B or C infection
16. Myocardial infarction within 4 months prior to randomization,
NYHA Class III or IV heart failure, uncontrolled angina, history
of severe coronary artery disease, severe uncontrolled ventricular
arrhythmias, sick sinus syndrome, or electrocardiographic
evidence of acute ischemia or Grade 3 conduction system
abnormalities unless subject has a pacemaker
17. Uncontrolled hypertension or uncontrolled diabetes within 14 days
prior to randomization
Eligibility Criteria - Exclusion
29. 18. Other malignancy within the past 3 years with the exception of
a) adequately treated basal cell carcinoma, squamous cell skin
cancer, or thyroid cancer; b) carcinoma in situ of the cervix or
breast; c) prostate cancer of Gleason Grade 6 or less with stable
prostate-specific antigen levels; or d) cancer considered cured by
surgical resection or unlikely to impact survival during the
duration of the study, such as localized transitional cell carcinoma
of the bladder or benign tumors of the adrenal or pancreas
19. Significant neuropathy (Grades 3–4, or Grade 2 with pain) within
14 days prior to randomization
20. Known history of allergy to Captisol® (a cyclodextrin derivative
used to solubilize carfilzomib)
21. Contraindication to any of the required concomitant drugs or
supportive treatments, including hypersensitivity to all
anticoagulation and antiplatelet options, antiviral drugs, or
intolerance to hydration due to preexisting pulmonary or cardiac impairment
22. Ongoing graft-vs-host disease
23. Subjects with pleural effusions requiring thoracentesis or ascites
requiring paracentesis within 14 days prior to randomization
24. Any other clinically significant medical disease or condition that,
in the Investigator’s opinion, may interfere with protocol
adherence or a subject’s ability to give informed consent
Eligibility Criteria - Exclusion
30. Rd Arm
Cycles 1 and higher (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Lenalidomide 25 mg PO on Days 1–21
CRd Arm
Cycles 1 through 12 (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Carfilzomib 20 mg/m2 IV on Days 1 and 2 of Cycle 1, escalating
to 27 mg/m2 IV on Days 8, 9, 15, 16 of Cycle 1 and continuing on
Days 1, 2, 8, 9, 15, 16 of Cycles 2 through Cycle 12
Lenalidomide 25 mg PO on Days 1–21
Cycles 13 through 18 (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Carfilzomib 27 mg/m2 IV on Days 1, 2, 15, 16
Lenalidomide 25 mg PO on Days 1–21
Cycles 19 and higher (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Lenalidomide 25 mg PO on Days 1–21
Study Treatment
31. Rd Arm
Cycles 1 and higher (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Lenalidomide 25 mg PO on Days 1–21
CRd Arm
Cycles 1 through 12 (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Carfilzomib 20 mg/m2 IV on Days 1 and 2 of Cycle 1, escalating
to 27 mg/m2 IV on Days 8, 9, 15, 16 of Cycle 1 and continuing on
Days 1, 2, 8, 9, 15, 16 of Cycles 2 through Cycle 12
Lenalidomide 25 mg PO on Days 1–21
Cycles 13 through 18 (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Carfilzomib 27 mg/m2 IV on Days 1, 2, 15, 16
Lenalidomide 25 mg PO on Days 1–21
Cycles 19 and higher (28 days each)
Dexamethasone 40 mg PO or IV on Days 1, 8, 15, 22
Lenalidomide 25 mg PO on Days 1–21
Study Treatment
32. Primary : Progression-free survival (PFS)
Endpoints
Secondary : Overall survival
Overall response rate: stringent complete response +
complete response + very good partial response +
partial response
Disease control rate: overall responses + stable disease
lasting at least 8 weeks
Duration of response
Safety
Time to progression (exploratory)
Time to next treatment (exploratory)