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Selinexor and Backbone Treatments of Multiple Myeloma Patients

Study acronym: STOMP
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Active, Not Recruiting → Recruiting Study sites: 24 to 25v49 Show 1 more changeShow less
    • Study sites: 24 to 25
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 25 to 24v48 Show 1 more changeShow less
    • Study sites: 25 to 24
  3. Study sites: 24 to 25v47
  4. Site contacts updated at 12 of 24 sitesv46
  5. Trial status: Active, Not Recruiting to Recruiting Study sites: 18 to 24v45 Show 1 more changeShow less
    • Study sites: 18 to 24
Show 43 earlier versionsHide 43 earlier versions
  1. Re-verified, no change to tracked fieldsv44
  2. Enrollment target: 518 to 300 Primary and study completion dates: Jan 2025 to Apr 2027 · Interventions: Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)… to Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)… · Eligibility criteria expanded, about 354 words · 3 morev43 Show 6 more changesShow less
    • Primary and study completion dates: Jan 2025 to Apr 2027
    • Interventions: Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)… to Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)…
    • Eligibility criteria expanded, about 354 words
    • Study description expanded, about 54 words
    • Study arms: 11 to 12
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv42
  4. Study sites: 20 to 18v41
  5. Re-verified, no change to tracked fieldsv40
  6. Trial status: Recruiting to Active, Not Recruiting Study sites: 24 to 20v39 Show 1 more changeShow less
    • Study sites: 24 to 20
  7. Site details revised at 1 of 24 sitesv38
  8. Primary and study completion dates: May 2022 to Jan 2025 Site details revised at 1 of 24 sitesv37 Show 1 more changeShow less
    • Site details revised at 1 of 24 sites
  9. Re-verified, no change to tracked fieldsv36
  10. Study sites revised (24)v35 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 21 to 24v34
  12. Study sites: 20 to 21v33
  13. Primary endpoints: 7 to 8 Enrollment target: 437 to 518 · Interventions: Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug), Elotuzumab (Drug), Ixazomib (Drug)… to Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)… · Eligibility criteria expanded, about 163 words · 2 morev32 Show 5 more changesShow less
    • Enrollment target: 437 to 518
    • Interventions: Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug), Elotuzumab (Drug), Ixazomib (Drug)… to Belantamab Mafodotin (Drug), Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug)…
    • Eligibility criteria expanded, about 163 words
    • Study description expanded, about 72 words
    • Study arms: 9 to 11

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 19 to 20v31
  15. Primary and study completion dates: May 2020 to May 2022v30
  16. Primary endpoints: 6 to 7 Enrollment target: 321 to 437 · Interventions: Bortezomib (Drug), Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug), Elotuzumab (Drug), Ixazomib (Drug)… · Eligibility criteria expanded, about 71 words · 4 morev29 Show 7 more changesShow less
    • Enrollment target: 321 to 437
    • Interventions: Bortezomib (Drug), Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Carfilzomib (Drug), Clarithromycin (Drug), Daratumumab (Drug), Dexamethasone (Drug), Elotuzumab (Drug), Ixazomib (Drug)…
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints shortened, about 9 words
    • Study description expanded, about 253 words
    • Site details revised at 2 of 19 sites
    • Study arms: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  17. 2 versions Re-verified since Dec 31, 2019, no change to tracked fieldsv27-v28
  18. Study sites: 18 to 19v26
  19. Re-verified, no change to tracked fieldsv25
  20. Study sites: 17 to 18v24
  21. Re-verified, no change to tracked fieldsv23
  22. Primary completion date: Mar 2019 to May 2020 Primary endpoints: 1 to 6 · Study sites: 16 to 17 · Completion date: Apr 2019 to May 2020 · 2 morev22 Show 5 more changesShow less
    • Primary endpoints: 1 to 6
    • Study sites: 16 to 17
    • Completion date: Apr 2019 to May 2020
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 15 to 16v21
  24. Study sites: 14 to 15v20
  25. Re-verified, no change to tracked fieldsv19
  26. Primary completion date: Mar 2018 to Mar 2019 Enrollment target: 262 to 321 · Completion date: Apr 2018 to Apr 2019 · Interventions: Bortezomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) · 5 morev18 Show 8 more changesShow less
    • Enrollment target: 262 to 321
    • Completion date: Apr 2018 to Apr 2019
    • Interventions: Bortezomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Carfilzomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug)
    • Eligibility criteria expanded, about 438 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 31 words
    • Site details revised at 1 of 14 sites
    • Study arms: 4 to 7

    See this version in full on ClinicalTrials.gov ↗

  27. 2 versions Re-verified since Nov 30, 2017, no change to tracked fieldsv16-v17
  28. Study sites: 17 to 14v15
  29. Re-verified, no change to tracked fieldsv14
  30. Enrollment target: 201 to 262 Interventions: Bortezomib (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) · Eligibility criteria expanded, about 28 words · Secondary endpoints: details revised at 1 of 1 entry · 3 morev13 Show 6 more changesShow less
    • Interventions: Bortezomib (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 6 words
    • Site details revised at 4 of 17 sites
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  31. Study sites: 16 to 17v12
  32. Primary endpoint revised Study sites: 15 to 16 · Eligibility criteria shortened, about 1 wordv11 Show 2 more changesShow less
    • Study sites: 15 to 16
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 16 to 15 Study title shortened, about 7 words · Study description shortened, about 3 wordsv10 Show 2 more changesShow less
    • Study title shortened, about 7 words
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  34. Re-verified, no change to tracked fieldsv9
  35. Primary completion date: Aug 2016 to Mar 2018 Completion date: Nov 2016 to Apr 2018 · Site details revised at 4 of 16 sitesv8 Show 2 more changesShow less
    • Completion date: Nov 2016 to Apr 2018
    • Site details revised at 4 of 16 sites
  36. Site details revised at 3 of 16 sitesv7
  37. Site contacts updated at 1 of 16 sitesv6
  38. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 140 to 201 · Study sites: 14 to 16 · Start date: Sep 2015 to Oct 2015 · 6 morev5 Show 9 more changesShow less
    • Enrollment target: 140 to 201
    • Study sites: 14 to 16
    • Start date: Sep 2015 to Oct 2015
    • Interventions: Bortezomib (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Dexamethasone (Drug), Lenalidomide (Drug), Pomalidomide (Drug), Selinexor (Drug)
    • Eligibility criteria expanded, about 529 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 6 words
    • Study title revised
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  39. Re-verified, no change to tracked fieldsv4
  40. Study Status, Contacts/Locationsv3
  41. Start date: Mar 2015 to Sep 2015v2
  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 study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: * Arm 1: Selinexor + dexamethasone + pomalidomide (SPd); enrollment complete * Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete * Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete * Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd); enrollment complete * Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete * Arm 6: Selinexor + dexamethasone + carfilzomib (SKd); enrollment complete * Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM; enrollment complete * Arm 8: Selinexor + dexamethasone + ixazomib (SNd); enrollment complete * Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd); enrollment complete * Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd); enrollment complete * Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd); enrollment complete * Arm 12: Selinexor + dexamethasone + mezigdomide (SMd); actively recruiting Selinexor pharmacokinetics: * PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 \[SPVd\], Arm 6 \[SKd\], Arm 8 \[SNd\], Arm 9 \[SPEd\], Arm 10 \[SBd\], and Arm 11 \[SDPd\]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor. This run-in period does not apply to Arm 12 (SMd).
Trial Details
NCT Number NCT02343042
Lead Sponsor Karyopharm Therapeutics Inc
Collaborators: Bristol-Myers Squibb
Conditions Multiple Myeloma
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov