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Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 747 to 748v32
  2. Site details revised at 1 of 747 sitesv31
  3. Trial sites expanded: 707 → 747 locationsv30
  4. 8 versions Re-verified since Sep 22, 2025, no change to tracked fieldsv22-v29
  5. Site details revised at 1 of 707 sitesv21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 596 to 707v20
  2. Re-verified, no change to tracked fieldsv19
  3. Start date: Apr 30, 2019 to Sep 16, 2019v18
  4. Primary completion date: Nov 30, 2023 to Dec 31, 2029
    • Study completion date: Nov 30, 2028 to Dec 31, 2029
    v17
  5. Re-verified, no change to tracked fieldsv16
  6. Site details revised at 16 of 596 sitesv15
  7. Study sites: 594 to 596v14
  8. Study sites revised (594)v13
  9. Study sites: 580 to 594v12
  10. Eligibility criteria expanded, about 78 wordsv11
  11. Study sites: 577 to 580v10
  12. Study sites: 574 to 577v9
  13. Study sites revised (574)v8
  14. Study sites: 507 to 574v7
  15. Study sites: 498 to 507v6
  16. Study sites: 497 to 498v5
  17. Study sites: 321 to 497v4
  18. Study sites: 6 to 321v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
Trial Details
NCT Number NCT03937635
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Smoldering Plasma Cell Myeloma
Related terms Smoldering Multiple Myeloma
Enrollment 288 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov