Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Phase 3 Active, not recruiting NCT01169337

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.

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)

Assessed every 4 weeks while on treatment up to 24 weeks · proportion of participants

2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)

Assessed every 3 months for 2 years · proportion of participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Tr — National Cancer Institute (NCI)
• Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previo — National Cancer Institute (NCI)
• Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment fo — University of Michigan Rogel Cancer Center
• Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) a — University of Alabama at Birmingham
• Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myel — M.D. Anderson Cancer Center
• Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (M — National Cancer Institute (NCI)

All trials