Patients receive bortezomib SC or IV on days 1, 4, 8, and 11 of courses 1-8 and days 1 and 8 of courses 9-12; lenalidomide PO daily on days 1-14; and dexamethasone PO daily on days 1, 2, 4, 5, 8, 9, 11, and 12 of courses 1-8 and days 1, 2, 8, and 9 of courses 9-12. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16; lenalidomide PO daily on days 1-21; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Patients receive lenalidomide PO daily on days 1-21. Treatment repeats every 4 weeks for 24 courses in the absences of disease progression or unacceptable toxicity.

Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Plasma Cell Myeloma

Bortezomib

Carfilzomib

Dexamethasone

Laboratory Biomarker Analysis

Lenalidomide

Quality-of-Life Assessment

Anchorage Associates in Radiation Medicine

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

Mayo Clinic in Arizona

CHI Saint Vincent Cancer Center Hot Springs

Veteran's Administration Medical Center

Kaiser Permanente-Deer Valley Medical Center

PCR Oncology

Sutter Auburn Faith Hospital

Sutter Cancer Centers Radiation Oncology Services-Auburn

Alta Bates Summit Medical Center-Herrick Campus

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Mills-Peninsula Medical Center

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Eden Hospital Medical Center

UC Irvine Health Cancer Center-Newport

Sutter Davis Hospital

Kaiser Permanente-Fremont

Palo Alto Medical Foundation-Fremont

Kaiser Permanente-Fresno

Saint Jude Medical Center

Fremont - Rideout Cancer Center

Memorial Medical Center

Kaiser Permanente-Modesto

Palo Alto Medical Foundation-Camino Division

Palo Alto Medical Foundation-Gynecologic Oncology

Sutter Cancer Research Consortium

Kaiser Permanente-Oakland

UC Irvine Health/Chao Family Comprehensive Cancer Center

Palo Alto Medical Foundation Health Care

Eisenhower Medical Center

Kaiser Permanente-Redwood City

Kaiser Permanente-Richmond

Kaiser Permanente-Roseville

Sutter Cancer Centers Radiation Oncology Services-Roseville

Sutter Roseville Medical Center

Kaiser Permanente Downtown Commons

Sutter Medical Center Sacramento

University of California Davis Comprehensive Cancer Center

Kaiser Permanente-South Sacramento

Kaiser Permanente - Sacramento

California Pacific Medical Center-Pacific Campus

Kaiser Permanente-San Francisco

Kaiser Permanente-Santa Teresa-San Jose

Kaiser Permanente San Leandro

Kaiser Permanente-San Rafael

Kaiser San Rafael-Gallinas

Kaiser Permanente Medical Center - Santa Clara

Palo Alto Medical Foundation-Santa Cruz

Kaiser Permanente-Santa Rosa

Sutter Pacific Medical Foundation

Kaiser Permanente-South San Francisco

Kaiser Permanente-Stockton

Palo Alto Medical Foundation-Sunnyvale

Gene Upshaw Memorial Tahoe Forest Cancer Center

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Kaiser Permanente Medical Center-Vacaville

Kaiser Permanente-Vallejo

Sutter Solano Medical Center/Cancer Center

Kaiser Permanente-Walnut Creek

Rocky Mountain Cancer Centers-Aurora

The Medical Center of Aurora

Boulder Community Hospital

Rocky Mountain Cancer Centers-Boulder

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

Denver Health Medical Center

Kaiser Permanente-Franklin

National Jewish Health-Main Campus

The Women's Imaging Center

Porter Adventist Hospital

Colorado Blood Cancer Institute

Presbyterian - Saint Lukes Medical Center - Health One

Rocky Mountain Cancer Centers-Midtown

SCL Health Saint Joseph Hospital

Rocky Mountain Cancer Centers-Rose

Rose Medical Center

Colorado Cancer Research Program NCORP

Mercy Medical Center

Southwest Oncology PC

Comprehensive Cancer Care and Research Institute of Colorado LLC

Swedish Medical Center

Mountain Blue Cancer Care Center

National Jewish Health-Western Hematology Oncology

Saint Mary's Hospital and Regional Medical Center

North Colorado Medical Center

Rocky Mountain Cancer Centers-Greenwood Village

Good Samaritan Medical Center

Kaiser Permanente-Rock Creek

Rocky Mountain Cancer Centers-Lakewood

Saint Anthony Hospital

Rocky Mountain Cancer Centers-Littleton

Littleton Adventist Hospital

Kaiser Permanente-Lone Tree

Rocky Mountain Cancer Centers-Sky Ridge

Sky Ridge Medical Center

Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Randomized Phase III Trial of Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients With Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)

The Kaplan-Meier (KM) method will be used to describe the overall survival function by arm. Sensitivity analysis will be done to evaluate OS in the subset of eligible patients and censoring patients at time of non-protocol therapy.

The Kaplan-Meier method will be used to describe the progression-free survival function by arm using all data while ignoring maintenance.

Will be compared between induction arms using Fisher?s exact test.

TTP distributions will be estimated by induction arm using Kaplan-Meier methods.

Duration of response will be estimated using Kaplan-Meier methods in the subset of patients achieving partial response or better while on induction therapy.

MRD evaluation by multiparametric flow cytometry will be conducted and patients classified as MRD negative, MRD positive or not evaluable. At each time point, MRD negative rates with two-sided 95% exact confidence intervals on each arm will be estimated. Patterns of change over time in MRD will also be evaluated using longitudinal regression analysis with general linear mixed effects models and GEE semi-parametric models. MRD negative rates will be compared between either induction or maintenance arms depending on the assessment time point using the Mantel-Haenszel test stratified either on intent to transplant at progression or induction arm (Step 1 and 2 stratification factors, respectively).

Will be analyzed using linear mixed models.

Will be analyzed with KM methods and Cox regression.

Descriptive statistics (absolute frequencies, percentages, mean, standard deviation [SD], median, range) will be used to characterize the study cohort by mutation incidence and expression levels at all time-points.

Descriptive statistics (absolute frequencies, percentages, mean, SD, median, range) will be used to characterize the study cohort by mutation incidence and expression levels at all time-points. Association of genotype data (binary) with categorical baseline patient and disease characteristics will be evaluated using chi-squared test or, if appropriate, Cochran-Armitage trend test. The Wilcoxon-rank sum test or, if appropriate, the Jonckheere-Terpstra test for trend will be used to assess differential expression levels with baseline patient and disease characteristic groups. The Kaplan-Meier method will be used to estimate progression-free and overall survival distributions and Cox regression to estimate hazard ratios by genotype status.

With samples submitted pre-registration, multiparametric flow cytometry will quantify circulating plasma cells (cPC) in terms of number of clonal events/150,000 collected total events and plasma cell proliferation in terms of the plasma cell labeling index (PCLI) percentage. The Kaplan-Meier method will be used to estimate induction progression-free survival and overall survival distributions and Cox regression used to estimate hazard ratios by dichotomized cPC and PCLI.

multiple myeloma/− nikotyna

Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

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