Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Who is this study for? Patients with Light Chain Deposition Disease, Smoldering Plasma Cell Myeloma
What treatments are being studied? Quality-of-Life Assessment
Status: Active, not recruiting
Location: See all (613) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 60 months, as confirmed by both of the following:

• Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells at any time before initiating study treatment, including a marrow which must be obtained by bone marrow aspiration and/or biopsy within 4 weeks prior to randomization

• Abnormal serum free light chain ratio (< 0.26 or > 1.65) by serum free light chain (FLC) assay; FLC assay must be performed within 28 days of randomization

• Patients must have measurable levels of monoclonal protein (M-protein): >= 1g/dL on serum protein electrophoresis or >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization

• Hemoglobin >= 11 g/dL within four weeks prior to randomization

• Platelet count >= 100,000/mm^3 within four weeks prior to randomization

• Absolute neutrophil count (ANC) >= 1,500/mm^3 within four weeks prior to randomization

• Calculated creatinine clearance >= 30 mL/min within four weeks prior to randomization

• Bilirubin =< 1.5 mg/dL within four weeks prior to randomization

• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGPT) (aspartate aminotransferase [AST]) =< 2.5 times upper limit of normal within four weeks prior to randomization

• Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day

• Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

• Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation

• Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years

• 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 prior to and again within 24 hours of starting cycle 1 of lenalidomide and 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 she starts taking 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

• Human immunodeficiency virus (HIV) infection is not excluded; HIV+ patients must meet the following criteria:

• Cluster of differentiation (CD)4 cell count >= 350/mm^3

• No history of acquired immune deficiency syndrome (AIDS)-related illness

• Not currently prescribed zidovudine or stavudine

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Mount Pleasant
Prisma Health Cancer Institute - Seneca
Seneca
Prisma Health Cancer Institute - Spartanburg
Spartanburg
South Dakota
Avera Cancer Institute-Aberdeen
Aberdeen
Rapid City Regional Hospital
Rapid City
Avera Cancer Institute
Sioux Falls
Avera McKennan Hospital and University Health Center
Sioux Falls
Tennessee
Jackson-Madison County General Hospital
Jackson
Regional Cancer Center at Indian Path Community Hospital
Kingsport
Wellmont Holston Valley Hospital and Medical Center
Kingsport
University of Tennessee - Knoxville
Knoxville
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth
Covenant Medical Center-Lakeside
Lubbock
Virginia
Kaiser Permanente-Burke Medical Center
Burke
Danville Regional Medical Center
Danville
Kaiser Permanente Tysons Corner Medical Center
Mclean
Southwest VA Regional Cancer Center
Norton
Vermont
Rutland Regional Medical Center
Rutland
Washington
MultiCare Auburn Medical Center
Auburn
Overlake Hospital Medical Center
Bellevue
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
Swedish Cancer Institute-Issaquah
Issaquah
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Capital Medical Center
Olympia
Providence - Saint Peter Hospital
Olympia
MultiCare Good Samaritan Hospital
Puyallup
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-First Hill
Seattle
MultiCare Allenmore Hospital
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Northwest NCI Community Oncology Research Program
Tacoma
Saint Joseph Medical Center
Tacoma
Compass Oncology Vancouver
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Clinic-Chippewa Center
Chippewa Falls
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Green Bay Oncology at Saint Vincent Hospital
Green Bay
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Gundersen Lutheran Medical Center
La Crosse
Dean Hematology and Oncology Clinic
Madison
University of Wisconsin Hospital and Clinics
Madison
Holy Family Memorial Hospital
Manitowoc
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Ascension Saint Mary's Hospital
Rhinelander
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Ascension Saint Michael's Hospital
Stevens Point
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aurora Cancer Care-Waukesha
Waukesha
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Diagnostic and Treatment Center
Weston
Marshfield Clinic - Weston Center
Weston
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
Charleston
Wyoming
Rocky Mountain Oncology
Casper
Welch Cancer Center
Sheridan
Other Locations
Ireland
Mater Misericordiae University Hospital
Dublin
Mater Private Hospital
Dublin
University College Hospital Galway
Galway
Puerto Rico
Fundacion De Investigacion de Diego
San Juan
Time Frame
Start Date: January 24, 2011
Estimated Completion Date: July 20, 2027
Participants
Target number of participants: 226
Treatments
Experimental: Arm A (lenalidomide)
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Active Comparator: Arm B (observation)
Patients undergo observation until progression to symptomatic myeloma.
Authors
Ehsan Malek, Victor T. Chang, Dennis E. Slater, Deborah W. Wilbur, Jan E. Duus, Madhav V. Dhodapkar, Thomas H. Openshaw, John Lister, Thomas J. Reid, Wei Song, Joseph W. Leach, Elizabeth A. Brem, Bruce J. Averbook, Asheesh Shipstone, Howard M. Gross, Jay W. Carlson, Steven J. Jubelirer, Darla K. Liles, Kanwarpal S. Kahlon, James R. Egner, Robert K. Stuart, Michael A. Schwartz, Timothy R. Wassenaar, Furhan Yunus, Vincent A. Rella, Robert M. Eisner, Raymond L. Comenzo, Jeffrey K. Giguere, Chris A. Rhoades, Dwight C. Kaufman, Timothy D. Moore, Abdulraheem M. Yacoub, Jeffrey H. Muler, Bradley W. Lash, James N. Atkins, Gregory A. Masters, Keren Sturtz, Hana F. Safah, Steven A. Akman, Bamidele A. Adesunloye, Carlos A. Alemany, Adedayo A. Onitilo, Joshua C. Lukenbill, Kurt Oettel, Brian L. Burnette, Alison K. Conlin, Frederick M. Schnell, Giampaolo Talamo, Robert D. Siegel, Donald B. Wender, Archie W. Wright, Doreen B. Brettler, Mary L. Kwok, Ranveer Nand, Larry D. Anderson, Marilyn A. McLaughlin, Kevin P. Barton, Hillard M. Lazarus, Peter R. Watson, Joshua P. Raff, Shaker R. Dakhil, Renee E. Funches, Joseph J. Vadakara, Ruby A. Grimm, John A. Lust, Natalie S. Callander, Lori Schleicher, Dulcinea D. Quintana, Daniel M. Anderson, James L. Wade, Benjamin T. Marchello, Sagar Lonial, Tami L. Bach, David E. Einspahr, Harvey E. Einhorn, Bret E. Friday, Srinivas S. Devarakonda, Ramakrishna R. Sudhindra, Dhimant R. Patel, Suman Kambhampati, Richard L. Deming, Mark A. Taylor, Allan D. Eisemann, Divaya Bhutani, Donald P. Quick, Robert A. Chapman, Rakesh Gaur, Howard R. Terebelo, Mitchell Haut, Neil Nagovski, Sharad A. Ghamande, Jorge A. Garcia-Young, Vodur S. Reddy, Joginder (Joe) Singh, Kathleen J. Yost, John A. Ellerton, Christopher M. Reynolds, John A. Keech, Michael E. O'Dwyer, Gamini S. Soori, Rakhee Vaidya
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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