Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

Running, not enrolling · Phase 3

Conditions studied: DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma

In brief

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Key facts

Study ID

NCT00098475

Run by

National Cancer Institute (NCI)

People needed

452

Starts

2004-11-03

Expected to finish

2026-10-23

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be diagnosed with symptomatic multiple myeloma within the past 90 days confirmed by the following:
• Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma which must be obtained within 4 weeks prior to randomization
• Measurable levels of monoclonal protein (M protein): >= 1.0 g/dL on serum protein electrophoresis or >= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization; both serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) are required to be performed within 28 days prior to randomization; 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
• 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
• Prior palliative and/or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to date of registration; patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma meeting all the eligibility criteria for this protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• 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 (intrauterine device [IUD], birth control pills, tubal ligation or partner's vasectomy) and one additional effective method (condom, diaphragm or cervical cap); 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 starting 4 weeks prior to and while taking CC5013 or thalidomide and for four weeks after discontinuing this therapy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or 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 with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months

You may not qualify if…

• No prior systemic therapy with the exception of bisphosphonates for multiple myeloma
• Prior 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 have had no seizures 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
• Patients with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible
• Patients must not have grade 2 or higher peripheral neuropathy due to other medical conditions at the time of randomization
• Patients must not have active, uncontrolled infection
• Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
• For patients registered prior to activation of Addendum # 6; 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
• For patients registered after activation of Addendum # 6; patients entering the expansion phase of the protocol, which tests anticoagulant prophylaxis, must be able and willing to be randomized between aspirin at 325 mg/day and Coumadin
• Female patients MUST NOT be pregnant or breastfeeding; due to the potential teratogenic properties of CC 5013, and the known teratogenicity associated with thalidomide, the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED

Where it is running

• Huntsville Hospital — Huntsville, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Saint Jude Medical Center — Fullerton, California, United States
• El Camino Hospital — Mountain View, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Saint Joseph Hospital - Cancer Centers of Colorado — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Banner North Colorado Medical Center - Loveland Campus — Loveland, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Martin Hospital South — Stuart, Florida, United States
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Atlanta Regional CCOP — Atlanta, Georgia, United States
• Augusta Oncology Associates PC-D'Antignac — Augusta, Georgia, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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