Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple … (NCT01169337) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
United States, Ireland, Puerto Rico226 participantsStarted 2011-01-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Patients must have no lytic lesions on skeletal surveys and no hypercalcemia (i.e., \>= 11 mg/dL)
* 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 \[A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)
Timeframe: Assessed every 4 weeks while on treatment up to 24 weeks
2
2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)