Study on Lenalidomide or Observation for Patients with High-Risk Smoldering Multiple Myeloma

Program Overview

This study aims to find out if lenalidomide, a drug that may boost the immune system and stop cancer cells from growing, is effective in treating patients with high-risk smoldering multiple myeloma. This type of multiple myeloma is currently not causing symptoms, and sometimes it may not need treatment until it progresses. The trial will compare the effects of taking lenalidomide to just observing the condition without treatment.

Description

The study is divided into two phases:

Phase II:

• Patients will take lenalidomide daily for 21 days in a 28-day cycle, as long as the disease does not progress or cause unacceptable side effects.

Phase III:

• Patients will be randomly assigned to one of two groups:
  • Group A: Will take lenalidomide daily for 21 days in a 28-day cycle, similar to Phase II.
  • Group B: Will be observed without treatment until the disease shows symptoms.

The study will monitor the safety of lenalidomide, how long patients remain free from disease progression, and overall survival rates. It will also assess the quality of life of patients and the impact of lenalidomide on immune function and bone health.

After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Eligibility Criteria

Locations