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NCT05911321 · ClinicalTrials.gov registry record · Phase 2

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

A Phase 2 study of Multiple Myeloma and Aging, sponsored by UNC Lineberger Comprehensive Cancer Center.

Active
Registry status
Phase 2
Development phase
6
Enrollment target
2
Study locations

NCT05911321: Active Phase 2 study of Multiple Myeloma and Aging, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT05911321 is a Phase 2 study of Multiple Myeloma and Aging that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 6 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05911321, a Phase 2 study of Multiple Myeloma and Aging, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
6 participants
Enrollment target
2
Study locations

Study Summary

This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).

Primary Outcome

Overall response rate (ORR) is defined as the percentage of participants achieving a partial response or better (≥PR) per IMWG criteria. The number and percentage of participants achieving at least a partial response were reported. Complete response (CR) requires negative serum and urine immunofixation, disappearance of plasmacytomas, and \<5% bone marrow plasma cells; stringent complete response (sCR) requires CR plus a normal free light chain ratio and no clonal plasma cells in bone marrow. V

Conditions Studied

Multiple Myeloma Aging Relapse Refractory Comorbidity

Interventions

  • DRUG Dexamethasone
  • DRUG Pomalidomide
  • DRUG Isatuximab

Study Locations (2)

North Carolina

  • Lineberger Comprehensive Cancer Center - Chapel Hill
  • Atrium Health Wake Forest Baptist Medical Center - Winston-Salem

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2023-12-05
Est. Completion 2028-03-26
Phase Phase 2
UNC Lineberger Comprehensive Cancer Center

366 total trials

What the registry record for NCT05911321 still lists

NCT05911321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (99% lower).

The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.

NCT05911321 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT05911321 about?

NCT05911321 is a clinical study titled "Isa-Pom-Dex in Elderly/Frail Subjects With RRMM". This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment...

What is the current status of trial NCT05911321?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2023-12-05. Estimated completion is 2028-03-26.

What conditions does trial NCT05911321 study?

This clinical trial studies the following conditions: Multiple Myeloma, Aging, Relapse, Refractory, Comorbidity.

What interventions are being tested in trial NCT05911321?

The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Isatuximab (DRUG).

Who is sponsoring clinical trial NCT05911321?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05911321 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for 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 NCT05911321's enrollment target sits among peer trials

6 434th of 438 higher than 5 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05911321, the US trial registry maintained by the National Library of Medicine. NCT05911321 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.