Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
Launched by ECOG-ACRIN CANCER RESEARCH GROUP · May 2, 2019
Trial Information
Current as of September 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective a combination of three medications—lenalidomide, dexamethasone, and daratumumab—are in treating patients with high-risk smoldering myeloma. Smoldering myeloma is a condition where abnormal plasma cells are present in the bone marrow but do not yet cause symptoms or require immediate treatment. The goal of this trial is to see if adding daratumumab, an immunotherapy drug that helps the immune system fight cancer, improves treatment outcomes compared to using lenalidomide and dexamethasone alone.
To be eligible for this trial, participants must be diagnosed with high-risk smoldering myeloma within the last year and meet specific health criteria, such as having certain levels of abnormal proteins in the blood and bone marrow. Participants will receive treatment and will be monitored closely for any changes in their condition. It's important to note that women who are pregnant or may become pregnant cannot participate due to potential risks to the fetus. Overall, this trial aims to find better treatment options for those at higher risk of developing full-blown myeloma, which can be a serious and life-threatening condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
- • Abnormal serum free light chain ratio of involved to uninvolved \>20, but less than 100 if the involved FLC is \>= 10 mg/dL by serum free light chain (FLC) assay
- • Serum M-protein level \>= 2 gm/dL
- • Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
- • \>20% plasma cells on biopsy or aspirate
- • Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
- • \>= 1 g/dL on serum protein electrophoresis (within 28 days prior to randomization).
- • \>= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization).
- • NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted.
- • SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization.
- • NOTE: 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 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.
- • Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., \> 11 mg/dL or 1mg/dL above upper limit of normal \[ULN\]).
- • Hemoglobin \>= 11 g/dL (within 28 days prior to randomization).
- • Platelet count \>= 100,000 cells/mm\^3 (within 28 days prior to randomization).
- • Absolute neutrophil count \>= 1500 cells/mm\^3 (within 28 days prior to randomization).
- • Calculated creatinine clearance \>= 30 mL/min (within 28 days prior to randomization).
- • Bilirubin =\< 1.5 mg/dL (within 28 days prior to randomization).
- • 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 (within 28 days prior to randomization).
- • Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis/aspirin.
- • Patients must not have more than one focal marrow lesion on magnetic resonance imaging (MRI) of either pelvis or spine. Patients with indwelling pacemakers and/or ICD (implantable cardioverter-defibrillator) that is known or suspected to be MRI incompatible will be excused from this test.
- • Concurrent use of erythropoietin is not allowed while on study therapy.
- • Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted. 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.
- • Patients must not have active, uncontrolled seizure disorder. Patients must not have had a seizure in the last 6 months.
- • Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome.
- • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- • Patients with monoclonal gammopathy of undetermined significance are not eligible.
- • Patients must not have grade 2 or higher peripheral neuropathy per CTCAE.
- • Patients must not have active, uncontrolled infection.
- • 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 should not have New York Heart Association classification III or IV heart failure at baseline.
- • 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.
- • Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of REMS.
- • Women must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days 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 28 days 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.
- • Human immunodeficiency virus (HIV)+ patients with undetectable HIV viral loads tested within 6 months are eligible.
- • Patients should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
- • Patients must not have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization
About Ecog Acrin Cancer Research Group
The ECOG-ACRIN Cancer Research Group is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative clinical trials and rigorous scientific inquiry. As a collaborative network of researchers, healthcare professionals, and institutions, ECOG-ACRIN focuses on improving cancer treatment and patient outcomes by conducting high-quality, multicenter studies. Their research spans various cancer types and includes a wide array of therapeutic approaches, emphasizing the integration of cutting-edge methodologies and patient-centered care. Committed to fostering collaboration and sharing knowledge, ECOG-ACRIN plays a vital role in transforming cancer care and enhancing the understanding of cancer biology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Woodland, California, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Perrysburg, Ohio, United States
Seattle, Washington, United States
Fort Worth, Texas, United States
Seattle, Washington, United States
Derby, Connecticut, United States
Fairfield, Connecticut, United States
Guilford, Connecticut, United States
North Haven, Connecticut, United States
Orange, Connecticut, United States
Waterbury, Connecticut, United States
Waterford, Connecticut, United States
Dekalb, Illinois, United States
Indianapolis, Indiana, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Martinsburg, West Virginia, United States
Stevens Point, Wisconsin, United States
Bayamon, Puerto Rico
Manati, Puerto Rico
Arroyo Grande, California, United States
Greenwich, Connecticut, United States
New Haven, Connecticut, United States
Springfield, Massachusetts, United States
Aitkin, Minnesota, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Hazleton, Pennsylvania, United States
Ashland, Wisconsin, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Denver, Colorado, United States
Golden, Colorado, United States
Lafayette, Colorado, United States
Thornton, Colorado, United States
Fort Dodge, Iowa, United States
Port Huron, Michigan, United States
Omaha, Nebraska, United States
Redmond, Oregon, United States
Burr Ridge, Illinois, United States
Detroit Lakes, Minnesota, United States
Fosston, Minnesota, United States
Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Denver, Colorado, United States
Springfield, Ohio, United States
Libertyville, Illinois, United States
Kingman, Arizona, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Burnsville, Minnesota, United States
San Juan, Puerto Rico
Bozeman, Montana, United States
Shelby, Michigan, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Stamford, Connecticut, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Oswego, New York, United States
Baytown, Texas, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
Richardson, Texas, United States
The Woodlands, Texas, United States
Goodyear, Arizona, United States
Glastonbury, Connecticut, United States
Shawano, Wisconsin, United States
Melrose Park, Illinois, United States
Westerly, Rhode Island, United States
Homer Glen, Illinois, United States
Missoula, Montana, United States
Hayward, Wisconsin, United States
Spooner, Wisconsin, United States
Superior, Wisconsin, United States
Greeley, Colorado, United States
Grand Island, Nebraska, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Lexington, Kentucky, United States
Seattle, Washington, United States
Seattle, Washington, United States
Des Moines, Iowa, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Centralia, Illinois, United States
Danville, Illinois, United States
New Albany, Ohio, United States
Guilford, Connecticut, United States
Greenville, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Merced, California, United States
Canton, Michigan, United States
Verona, New York, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
O'fallon, Illinois, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Loveland, Colorado, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Madison, Wisconsin, United States
Kinston, North Carolina, United States
Washington, North Carolina, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Grand Rapids, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Kenansville, North Carolina, United States
Richlands, North Carolina, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Macomb Township, Michigan, United States
Shelby Township, Michigan, United States
Patients applied
Trial Officials
Natalie S Callander
Principal Investigator
ECOG-ACRIN Cancer Research Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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