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S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

Study acronym: DRAMMATIC
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 2 months later Jul 1, 2029 → Sep 2032
See other at-risk trials from SWOG Cancer Research Network

Record History

  1. Primary completion pushed from Jul 1, 2029 to Sep 2032 Interventions: Daratumumab/rHuPH20 (Drug), Lenalidomide (Drug) to Daratumumab/rHuPH20 (Drug), Lenalidomide (Drug) · Eligibility criteria shortened, about 8 words · Secondary endpoints: details revised at 3 of 3 entries · 2 more Show 5 more changesShow less
    • Interventions: Daratumumab/rHuPH20 (Drug), Lenalidomide (Drug) to Daratumumab/rHuPH20 (Drug), Lenalidomide (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised at 68 of 842 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 842 of 842 sitesv15 Show 1 more changeShow less
    • Site details revised at 842 of 842 sites
  3. Study sites: 728 to 842v14
  4. Re-verified, no change to tracked fieldsv13
  5. Study sites: 699 to 728v12
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Jun 27, 2019 to Aug 13, 2019v11
  2. Study sites: 582 to 699v10
  3. Collaborators: 3 to 2v9 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 534 to 582v8
  5. Re-verified, no change to tracked fieldsv7
  6. Study sites: 517 to 534v6
  7. Study sites: 506 to 517v5
  8. Study title revisedv4 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 466 to 506v3
  10. Study sites: 100 to 466v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Trial Details
NCT Number NCT04071457
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), Janssen, LP
Conditions Multiple Myeloma
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov