Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Key facts

Study ID

NCT00602641

Run by

National Cancer Institute (NCI)

People needed

306

Starts

2008-02-29

Expected to finish

2027-02-20

Last updated by the study team

2026-07-02

Who can join

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

You may qualify if…

• 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:

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Sparks Regional Medical Center — Fort Smith, Arkansas, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Memorial Medical Center — Modesto, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• San Diego VA Medical Center — San Diego, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Foothills Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• AdventHealth Porter — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Saint Joseph Hospital - Cancer Centers of Colorado — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Western States Cancer Research NCORP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• Banner North Colorado Medical Center — Greeley, Colorado, United States
• CommonSpirit Saint Anthony Hospital Cancer Center — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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