This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone).
SparkCures ID | 1098 |
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Trial Phase | Phase 3 |
Enrollment | 1450 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
Inclusion Criteria:
STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:
STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
Exclusion Criteria:
STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol
STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
The following criteria is provided for health care professionals.
Inclusion Criteria:
STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:
STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
Exclusion Criteria:
STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol
STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
This clinical trial is not limited to the sites that you find listed below. If you are a patient and do not see your center listed as a participating site below, please contact SparkCures at (888) 828-2206 for additional assistance.
The following is a listing of trial locations that are open and accepting patients.
SparkCures Verified Accurate, up-to-date information. Learn more
Anchorage, AK
Anchorage, AK
Anchorage, AK
Centennial, CO
Colorado Springs, CO
Colorado Springs, CO
Colorado Springs, CO
Denver, CO
Durango, CO
Durango, CO
Lakewood, CO
Longmont, CO
Longmont, CO
Parker, CO
Pueblo, CO
Glastonbury, CT
Greenwich, CT
North Haven, CT
Orange, CT
Torrington, CT
Trumbull, CT
Waterford, CT
Lewes, DE
Newark, DE
Rehoboth Beach, DE
Wilmington, DE
Fort Lauderdale, FL
Pensacola, FL
Atlanta, GA
Ames, IA
Ames, IA
Boone, IA
Cedar Rapids, IA
Clive, IA
Council Bluffs, IA
Creston, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
West Des Moines, IA
West Des Moines, IA
Boise City, ID
Coeur d'Alene, ID
Fruitland, ID
Meridian, ID
Post Falls, ID
Sandpoint, ID
Twin Falls, ID
Aurora, IL
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Chicago, IL
Danville, IL
Dixon, IL
Effingham, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Geneva, IL
Kewanee, IL
Macomb, IL
Mattoon, IL
Melrose Park, IL
Mount Vernon, IL
Orland Park, IL
Pekin, IL
Peoria, IL
Peoria, IL
Princeton, IL
Springfield, IL
Springfield, IL
Urbana, IL
Warrenville, IL
Yorkville, IL
Richmond, IN
Bardstown, KY
Corbin, KY
Lexington, KY
Lexington, KY
Louisville, KY
Louisville, KY
Louisville, KY
Shepherdsville, KY
Boston, MA
Frederick, MD
Battle Creek, MI
Brighton, MI
Canton, MI
Chelsea, MI
Flint, MI
Flint, MI
Grand Rapids, MI
Grand Rapids, MI
Kalamazoo, MI
Kalamazoo, MI
Kalamazoo, MI
Lansing, MI
Livonia, MI
Muskegon, MI
Niles, MI
Pontiac, MI
Reed City, MI
Saginaw, MI
St. Joseph, MI
St. Joseph, MI
Traverse City, MI
Ypsilanti, MI
Bemidji, MN
Burnsville, MN
Cambridge, MN
Coon Rapids, MN
Edina, MN
Fridley, MN
Maple Grove, MN
Maplewood, MN
Maplewood, MN
Minneapolis, MN
Minneapolis, MN
Minneapolis, MN
Monticello, MN
New Ulm, MN
Princeton, MN
Robbinsdale, MN
Rochester, MN
Shakopee, MN
St. Louis Park, MN
St. Paul, MN
St. Paul, MN
Stillwater, MN
Waconia, MN
Willmar, MN
Woodbury, MN
Wyoming, MN
Ballwin, MO
Bolivar, MO
Branson, MO
Cape Girardeau, MO
Cape Girardeau, MO
Jefferson City, MO
Joplin, MO
Sainte Genevieve, MO
Springfield, MO
Springfield, MO
St. Joseph, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
Sullivan, MO
Sunset Hills, MO
Washington, MO
Anaconda, MT
Billings, MT
Bozeman, MT
Great Falls, MT
Great Falls, MT
Kalispell, MT
Missoula, MT
Missoula, MT
Clinton, NC
Goldsboro, NC
Jacksonville, NC
Bismarck, ND
Fargo, ND
Fargo, ND
Fargo, ND
Grand Island, NE
Kearney, NE
Omaha, NE
Omaha, NE
Papillion, NE
Albuquerque, NM
Glens Falls, NY
Stony Brook, NY
Belpre, OH
Centerville, OH
Chillicothe, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cleveland, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Dayton, OH
Dayton, OH
Delaware, OH
Findlay, OH
Forestville, OH
Franklin, OH
Greenville, OH
Kettering, OH
Lancaster, OH
Lima, OH
Marietta, OH
Marion, OH
Middletown, OH
Mount Vernon, OH
Newark, OH
Newark, OH
Portsmouth, OH
Sidney, OH
Springfield, OH
Toledo, OH
Toledo, OH
Toledo, OH
Westerville, OH
White Oak, OH
Whitehall, OH
Zanesville, OH
Oklahoma City, OK
Clackamas, OR
Coos Bay, OR
Newberg, OR
Allentown, PA
Chadds Ford, PA
West Reading, PA
Westerly, RI
Charleston, SC
Charleston, SC
Greenville, SC
Greenville, SC
Sioux Falls, SD
Bryan, TX
Salt Lake City, UT
Charlottesville, VA
Richmond, VA
Bellingham, WA
Bremerton, WA
Burien, WA
Edmonds, WA
Enumclaw, WA
Everett, WA
Federal Way, WA
Lakewood, WA
Longview, WA
Seattle, WA
Seattle, WA
Seattle, WA
Silverdale, WA
Vancouver, WA
Walla Walla, WA
Baraboo, WI
Burlington, WI
Chippewa Falls, WI
Eau Claire, WI
Grafton, WI
Green Bay, WI
Kenosha, WI
La Crosse, WI
Ladysmith, WI
Madison, WI
Marshfield, WI
Milwaukee, WI
Milwaukee, WI
Milwaukee, WI
Minocqua, WI
Mount Pleasant, WI
Mukwonago, WI
Oconomowoc, WI
Oconomowoc, WI
Oshkosh, WI
Rice Lake, WI
Sheboygan, WI
Stevens Point, WI
Two Rivers, WI
Waukesha, WI
Wausau, WI
Wauwatosa, WI
West Allis, WI
Weston, WI
Wisconsin Rapids, WI
Cody, WY
Sheridan, WY
The following is a listing of trial locations that are not currently open and accepting patients.
Seaford, DE
Indianapolis, IN
Mayfield Heights, OH
Anchorage, AK
Anchorage, AK
Anchorage, AK
Centennial, CO
Colorado Springs, CO
Colorado Springs, CO
Colorado Springs, CO
Denver, CO
Durango, CO
Durango, CO
Lakewood, CO
Longmont, CO
Longmont, CO
Parker, CO
Pueblo, CO
Glastonbury, CT
Greenwich, CT
North Haven, CT
Orange, CT
Torrington, CT
Trumbull, CT
Waterford, CT
Lewes, DE
Newark, DE
Rehoboth Beach, DE
Seaford, DE
Wilmington, DE
Fort Lauderdale, FL
Pensacola, FL
Atlanta, GA
Boise City, ID
Coeur d'Alene, ID
Fruitland, ID
Meridian, ID
Post Falls, ID
Sandpoint, ID
Twin Falls, ID
Aurora, IL
Bloomington, IL
Burr Ridge, IL
Canton, IL
Carbondale, IL
Carterville, IL
Carthage, IL
Centralia, IL
Chicago, IL
Danville, IL
Dixon, IL
Effingham, IL
Effingham, IL
Eureka, IL
Galesburg, IL
Galesburg, IL
Geneva, IL
Kewanee, IL
Macomb, IL
Mattoon, IL
Melrose Park, IL
Mount Vernon, IL
Orland Park, IL
Pekin, IL
Peoria, IL
Peoria, IL
Princeton, IL
Springfield, IL
Springfield, IL
Urbana, IL
Warrenville, IL
Yorkville, IL
Indianapolis, IN
Richmond, IN
Ames, IA
Ames, IA
Boone, IA
Cedar Rapids, IA
Clive, IA
Council Bluffs, IA
Creston, IA
Des Moines, IA
Des Moines, IA
Des Moines, IA
Fort Dodge, IA
Jefferson, IA
Marshalltown, IA
West Des Moines, IA
West Des Moines, IA
Bardstown, KY
Corbin, KY
Lexington, KY
Lexington, KY
Louisville, KY
Louisville, KY
Louisville, KY
Shepherdsville, KY
Frederick, MD
Boston, MA
Battle Creek, MI
Brighton, MI
Canton, MI
Chelsea, MI
Flint, MI
Flint, MI
Grand Rapids, MI
Grand Rapids, MI
Kalamazoo, MI
Kalamazoo, MI
Kalamazoo, MI
Lansing, MI
Livonia, MI
Muskegon, MI
Niles, MI
Pontiac, MI
Reed City, MI
Saginaw, MI
St. Joseph, MI
St. Joseph, MI
Traverse City, MI
Ypsilanti, MI
Bemidji, MN
Burnsville, MN
Cambridge, MN
Coon Rapids, MN
Edina, MN
Fridley, MN
Maple Grove, MN
Maplewood, MN
Maplewood, MN
Minneapolis, MN
Minneapolis, MN
Minneapolis, MN
Monticello, MN
New Ulm, MN
Princeton, MN
Robbinsdale, MN
Rochester, MN
Shakopee, MN
St. Louis Park, MN
St. Paul, MN
St. Paul, MN
Stillwater, MN
Waconia, MN
Willmar, MN
Woodbury, MN
Wyoming, MN
Ballwin, MO
Bolivar, MO
Branson, MO
Cape Girardeau, MO
Cape Girardeau, MO
Jefferson City, MO
Joplin, MO
Sainte Genevieve, MO
Springfield, MO
Springfield, MO
St. Joseph, MO
St. Louis, MO
St. Louis, MO
St. Louis, MO
Sullivan, MO
Sunset Hills, MO
Washington, MO
Anaconda, MT
Billings, MT
Bozeman, MT
Great Falls, MT
Great Falls, MT
Kalispell, MT
Missoula, MT
Missoula, MT
Grand Island, NE
Kearney, NE
Omaha, NE
Omaha, NE
Papillion, NE
Albuquerque, NM
Glens Falls, NY
Stony Brook, NY
Clinton, NC
Goldsboro, NC
Jacksonville, NC
Bismarck, ND
Fargo, ND
Fargo, ND
Fargo, ND
Belpre, OH
Centerville, OH
Chillicothe, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cincinnati, OH
Cleveland, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Columbus, OH
Dayton, OH
Dayton, OH
Delaware, OH
Findlay, OH
Forestville, OH
Franklin, OH
Greenville, OH
Kettering, OH
Lancaster, OH
Lima, OH
Marietta, OH
Marion, OH
Mayfield Heights, OH
Middletown, OH
Mount Vernon, OH
Newark, OH
Newark, OH
Portsmouth, OH
Sidney, OH
Springfield, OH
Toledo, OH
Toledo, OH
Toledo, OH
Westerville, OH
White Oak, OH
Whitehall, OH
Zanesville, OH
Oklahoma City, OK
Clackamas, OR
Coos Bay, OR
Newberg, OR
Allentown, PA
Chadds Ford, PA
West Reading, PA
Westerly, RI
Charleston, SC
Charleston, SC