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NCT04764942 · ClinicalTrials.gov registry record · Phase 1
Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial
A Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04764942: Active Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Mayo Clinic.
NCT04764942 is a Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 39 participants, below the 47-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04764942, a Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial identifies the best dose and side effects of selinexor, and how well it works when given in combination with pomalidomide and dexamethasone with or without carfilzomib in treating patients with multiple myeloma that has come back (relapsed) and does not respond to treatment with proteasome inhibitors and immunomodulatory drugs (refractory). Selinexor is an oral agent that blocks a protein called Exportin 1 (XPO1 or CRM1) that is abundant in a wide variety of cancers, including multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pomalidomide may stop the growth of blood vessels, stimulate the immune system, and kill cancer cells. Anti-inflammatory drugs, such as dexamethasone may lower the body's immune response and are used with other drugs in the treatment of some types of cancer. The addition of selinexor may allow better control of relapsed refractory multiple myeloma than is possible with pomalidomide and dexamethasone with or without carfilzomib.
Primary Outcome
A standard 3+3 phase I design will be utilized. Three patients will be treated at each dose level and observed for a minimum of four weeks (i.e. one full cycle) before new patients are treated. Doses will not be escalated in any individual patient.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Carfilzomib
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2027-12-17 |
| Phase | Phase 1 |
What the registry record for NCT04764942 still lists
NCT04764942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 47-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (17% lower).
The record links to 2 conditions, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04764942 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04764942 about?
NCT04764942 is a clinical study titled "Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial". This phase I/II trial identifies the best dose and side effects of selinexor, and how well it works when given in combination with pomalidomide and dexamethasone with or without carfilzomib in treating patients with multiple myeloma that has come back (relapsed) and does not respond to treatment wit...
What is the current status of trial NCT04764942?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2021-05-06. Estimated completion is 2027-12-17.
What conditions does trial NCT04764942 study?
This clinical trial studies the following conditions: Refractory Multiple Myeloma, Recurrent Multiple Myeloma.
What interventions are being tested in trial NCT04764942?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Dexamethasone (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT04764942?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04764942 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04764942's enrollment target sits among peer trials
39 22nd of 67 higher than 46 of 67 other Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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