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DREAMM 7NCT04246047

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 3
Primary completion
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Record History

All 42 versions: 40 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words Show 4 more changesShow less
    • Trial sites expanded: 69 → 143 locations
    • Study completion pushed from Jun 30, 2028 to Oct 8, 2029
    • Secondary endpoints: details revised at 6 of 22 entries
    • Publications: 4 to 5
  2. Study sites: 144 to 69
    • Study completion date: Jun 19, 2026 to Jun 30, 2028
    v41
  3. Results first posted: Oct 24, 2024v40 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 571 to 494
    • Study sites: 151 to 144
    • Secondary endpoints: 19 to 22
  4. Primary completion date changed from estimate of Sep 26, 2023 to Oct 2, 2023
    • Secondary endpoints: details revised at 2 of 19 entries
    • Site details revised at 4 of 151 sites
    v39
  5. Enrollment target: estimated 575 to confirmed 571
    • Primary completion date: Jul 28, 2023 to Sep 26, 2023
    • Secondary endpoints: 20 to 19
    • Study description shortened, about 37 words
    v38
Show 34 earlier versionsHide 34 earlier versions
  1. Primary completion date: Apr 21, 2023 to Jul 28, 2023
    • Site details revised at 24 of 151 sites
    v37
  2. Study sites: 152 to 151v36
  3. Site details revised at 5 of 152 sitesv35
  4. Study sites: 150 to 152v34
  5. Study sites: 147 to 150v33
  6. Study sites: 144 to 147v32
  7. Study sites: 141 to 144v31
  8. Enrollment target: 478 to 575
    • Study sites: 146 to 141
    • Primary completion date: Jun 21, 2023 to Apr 21, 2023
    • Study completion date: Aug 13, 2026 to Jun 19, 2026
    v29
  9. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 145 to 146
    v28
  10. Study sites: 134 to 145v27
  11. Study sites: 125 to 134v26
  12. Study sites: 94 to 125v25
  13. Study sites: 82 to 94v24
  14. Study sites: 81 to 82v23
  15. Study sites: 74 to 81v22
  16. Study sites: 70 to 74v21
  17. Study sites: 66 to 70v20
  18. Study sites: 63 to 66v19
  19. Study sites: 57 to 63
    • Start date: Apr 20, 2020 to May 7, 2020
    v18
  20. Study sites: 51 to 57v17
  21. Study sites: 45 to 51
    • Start date: May 7, 2020 to Apr 20, 2020
    v16
  22. Study sites: 44 to 45v15
  23. Study sites: 39 to 44v14
  24. Study sites: 37 to 39v13
  25. Eligibility criteria shortened, about 5 wordsv12 Show 4 more changesShow less
    • Study sites: 15 to 37
    • Primary completion date: Jan 12, 2023 to Jun 21, 2023
    • Study completion date: Jun 16, 2026 to Aug 13, 2026
    • Study description expanded, about 3 words
  26. Study sites: 10 to 15v11
  27. Study sites: 7 to 10v10
  28. Study sites: 6 to 7v9
  29. Study sites: 5 to 6v8
  30. Study sites: 4 to 5v7
  31. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 4
    • Start date changed from estimate of Apr 29, 2020 to May 7, 2020
    v6
  32. Study sites: 0 to 2
    • Start date: Apr 15, 2020 to Apr 29, 2020
    v5
  33. Study completion date: Jun 15, 2026 to Jun 16, 2026
    • Start date: Apr 9, 2020 to Apr 15, 2020
    v4
  34. Primary completion date: Jan 13, 2023 to Jan 12, 2023v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free Survival (PFS)
Timeframe: Up to approximately 41 months

Secondary (22)

Complete Response Rate (CRR)
Overall Response Rate (ORR)
Clinical Benefit Rate (CBR)
Duration of Response (DoR)
Time to Response (TTR)
Show 17 moreShow less
Time to Progression (TTP)
Overall Survival (OS)
Progression-free Survival on Subsequent Line of Therapy (PFS2)
Minimal Residual Disease (MRD) Negativity Rate
Number of Participants With Adverse Events (AEs)
Number of Participants With Clinically Significant Changes in Hematology Parameters
Number of Participants With Clinically Significant Changes in Clinical Chemistry
Number of Participants With Clinically Significant Changes in Urine Dipstick
Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination
Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points
Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points
Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Titers of ADAs Against Belantamab Mafodotin
Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Change From Baseline in HRQoL as Measured by EORTC IL52

Arms and interventions

Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)Experimental
Daratumumab and Bortezomib plus Dexamethasone (Arm B)Active comparator

Drugs: Belantamab mafodotin, Daratumumab, Bortezomib, Dexamethasone

Sites

143 sites in 20 countries

Japan 19, Australia 13, China 12, Spain 12, Italy 10, Poland 8, Russia 8, Brazil 7, United Kingdom 7, Germany 6, United States 6, France 5, South Korea 5, Belgium 4, Canada 4, Czechia 4, Israel 4, New Zealand 4, Greece 3, Netherlands 2