Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
Patients must have a confirmed diagnosis of symptomatic myeloma; for the original diagnosis of myeloma patients should have met the following criteria at one point in their disease course:
- Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis namely; at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
- NOTE: Patients with asymptomatic smoldering myeloma (serum m protein >= 3 gm/dL or bone marrow plasma cells >= 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein < 3 gm/dL and bone marrow plasma cells < 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible
Patients must be > 65 and have declined alternative treatment OR patients who are >= 18 < 65 are eligible if they:
- Are not a candidate for autologous stem cell transplantation in the opinion of the treating physician OR
- Have declined transplant or other alternative treatment
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
All tests below must be performed within 28 days prior to randomization:
- Serum free light chain assay
- Kappa free light chain
Lambda free light chain
- NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine; measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL; measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr
- NOTE: urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable; urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response
- Hemoglobin > 7 g/dL
- Platelet count > 75,000 cells/mm^3
- Absolute neutrophil count > 1000 cells/mm^3
- Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) > 60 mL/min
- Total bilirubin =< 1.5 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) [alanine aminotransferase (ALT)] and serum glutamic oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST)] =< 2.5 times the upper limit of normal
- Patients must be previously untreated for myeloma, although prior treatment for myeloma with prednisone or dexamethasone for less than 4 weeks total dosing alone or in combination with thalidomide or lenalidomide for less than 2 weeks total dosing is allowable
- Patients may be receiving bisphosphonates or growth factors (erythropoietin) for multiple myeloma; although erythropoietin is allowed, it is strongly discouraged due to increased risk of thrombosis when employed alongside thalidomide and/or lenalidomide therapy
- Patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
Patients must not have uncontrolled inter-current illness that would limit compliance with the study including:
- Uncontrolled hypertension
- Symptomatic congestive heart failure
- Unstable angina
- Uncontrolled cardiac arrhythmia
- Uncontrolled psychiatric illness or social situation
- Prior history of Stevens Johnson syndrome
- Patients must not have grade 2 or higher peripheral neuropathy
- Patients must not have an active, uncontrolled infection
- Female patients MUST NOT be pregnant or breastfeeding; the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED; for women of childbearing potential, a negative serum pregnancy test is required within 10-14 days prior to randomization; for female patients of childbearing potential a negative serum pregnancy test must be repeated within 24 hours prior to initiation of treatment, weekly for the first 4 weeks of treatment and then every 4 weeks if the patient's periods are regular or every 2 weeks if they are not; women of childbearing potential must be willing to refrain from sexual intercourse or must be willing to employ a dual method of contraception, one of which is highly effective [intrauterine device (IUD), birth control pills, tubal ligation or partner's vasectomy] and another additional method (condom, diaphragm or cervical cap) starting 4 weeks prior to and while taking lenalidomide and thalidomide and for four weeks after discontinuing this therapy; the male partner of a female using a single form of birth control should use a condom regardless of his vasectomy status
- Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide and thalidomide and for 4 weeks after stopping treatment
- Patients must not have had a second active malignancy requiring treatment within the last 2 years, with the exceptions of basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix
Sites / Locations
- Providence Hospital
- Mayo Clinic in Arizona
- Sparks Regional Medical Center
- UC San Diego Moores Cancer Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- University of California Davis Comprehensive Cancer Center
- UC San Diego Medical Center - Hillcrest
- Kaiser Permanente-San Diego Mission
- San Diego VA Medical Center
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Western States Cancer Research NCORP
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- MedStar Georgetown University Hospital
- Holy Cross Hospital
- Broward Health Medical Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Mount Sinai Medical Center
- Phoebe Putney Memorial Hospital
- Piedmont Hospital
- Emory University Hospital/Winship Cancer Institute
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- Augusta University Medical Center
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Dublin Hematology Oncology Care PC
- Piedmont Fayette Hospital
- Northside Hospital - Gwinnett
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- University of Illinois
- Swedish Covenant Hospital
- University of Chicago Comprehensive Cancer Center
- Heartland Cancer Research NCORP
- Eureka Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Saint Francis Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Cottage
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Havana
- Mason District Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Hopedale Medical Complex - Hospital
- Duly Health and Care Joliet
- Illinois CancerCare-Kewanee Clinic
- Kewanee Hospital
- AMITA Health Adventist Medical Center
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Swedish American Hospital
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Franciscan Saint Francis Health-Beech Grove
- IU Health Arnett Cancer Care
- Franciscan Saint Anthony Health-Michigan City
- The Community Hospital
- Reid Health
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- University of Iowa Healthcare Cancer Services Quad Cities
- Medical Oncology and Hematology Associates-West Des Moines
- Genesis Medical Center - East Campus
- Genesis Cancer Care Institute
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Iowa City VA Healthcare System
- Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cedar Valley Medical Specialists
- MercyOne Waterloo Cancer Center
- Lawrence Memorial Hospital
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Wesley Medical Center
- Doctors Carrol, Sheth, Raghavan
- Owensboro Health Mitchell Memorial Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- Ochsner Medical Center Jefferson
- Mercy Hospital
- Greater Baltimore Medical Center
- Walter Reed National Military Medical Center
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Beaumont Hospital - Dearborn
- Ascension Saint John Hospital
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Saint John Macomb-Oakland Hospital
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Woodwinds Health Campus
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Capital Region Southwest Campus
- Saint Louis Cancer and Breast Institute-South City
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Comprehensive Cancer Care PC
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- Nevada Cancer Institute-Summerlin Campus
- Nevada Cancer Research Foundation NCORP
- Veterans Adminstration New Jersey Health Care System
- Virtua Memorial
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- Rutgers New Jersey Medical School
- Virtua Voorhees
- Montefiore Medical Center-Wakefield Campus
- Kings County Hospital
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Hematology Oncology Associates of Central New York-East Syracuse
- Veterans Affairs New York Harbor Healthcare System-Manhattan Campus
- University of Rochester
- Stony Brook University Medical Center
- Syracuse Veterans Administration Medical Center
- Novant Health Presbyterian Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Margaret R Pardee Memorial Hospital
- Vidant Oncology-Kinston
- UNC Rex Healthcare
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Summa Health System - Akron Campus
- Summa Health System - Barberton Campus
- Mary Rutan Hospital
- Cleveland Clinic Mercy Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- Case Western Reserve University
- MetroHealth Medical Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Dayton NCI Community Oncology Research Program
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- Clackamas Radiation Oncology Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Adventist Medical Center
- Providence Saint Vincent Medical Center
- Compass Oncology Rose Quarter
- Legacy Emanuel Hospital and Health Center
- Legacy Meridian Park Hospital
- Bryn Mawr Hospital
- Adams Cancer Center
- Cherry Tree Cancer Center
- Penn State Milton S Hershey Medical Center
- Central PA Hematology-Medical Oncology Associates PC
- Lewistown Hospital
- Paoli Memorial Hospital
- Einstein Medical Center Philadelphia
- Phoenixville Hospital
- Guthrie Medical Group PC-Robert Packer Hospital
- Mount Nittany Medical Center
- UPMC Susquehanna
- Lankenau Medical Center
- Main Line Health NCORP
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Avera McKennan Hospital and University Health Center
- Sanford USD Medical Center - Sioux Falls
- Cookeville Regional Medical Center
- Jackson-Madison County General Hospital
- The Jackson Clinic PA
- Vanderbilt University/Ingram Cancer Center
- Scott and White Memorial Hospital
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Sovah Health Martinsville
- MultiCare Auburn Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- MultiCare Good Samaritan Hospital
- Swedish Medical Center-First Hill
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- Legacy Salmon Creek Hospital
- West Virginia University Charleston Division
- Camden Clark Medical Center
- Princeton Community Hospital
- ThedaCare Regional Cancer Center
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Saint Agnes Hospital/Agnesian Cancer Center
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Carbone Cancer Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth Oconomowoc Memorial Hospital
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Ascension Saint Michael's Hospital
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Rambam Medical Center
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (thalidomide)
Arm II (lenalidomide)
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression.
INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression.