Trial · NCT05911321
Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
NCT05911321, Phase 2, Active not recruiting, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isa-Pom-Dex in Elderly/Frail Subjects With RRMM. Trials, record NCT05911321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05911321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
- NCT number
- NCT05911321
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
- Interventions
- Isatuximab, Pomalidomide, Dexamethasone
- First posted
- 2023-06-22
- Last updated
- 2026-06-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 12 weeks | 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. Very good partial response (VGPR) is defined as M-protein detectable by immunofixation but not electrophoresis, or a ≥90% reduction in serum M-protein with urine M-protein \<100 mg/24h. Partial response (PR) is defined as a ≥50% reduction in serum M-protein and a ≥90% reduction in 24-hour urine M-protein (or to \<200 mg/24h), with a ≥50% reduction in plasmacytomas if present at baseline. |
| Secondary | Treatment Related Adverse Events Rate | Up to 12 weeks | All treatment-related adverse events as defined by changes from baseline utilizing National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0. NCI-CTCAE is a descriptive terminology utilized for AE reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Secondary | Treatment Failure-free Survival (TFFS) | Up to 3 years | TFFS is defined as the time start from the first day of study therapy until discontinuation for any reason, including disease progression, toxicity, or death. Progressive disease: Serum M-protein: absolute increase must be ≥ 0.5 g/dL, ≥ 1 g/dL if the lowest M component was ≥ 5 g/dL; absolute Urine M-protein increase≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \> 10 mg/dL; without measurable involved FLC levels, bone marrow plasma cell percentage irrespective of baseline status Appearance of a new lesion(s), ≥ 50% increase from nadir \> 1 lesion, or ≥ 50% increase in the longest diameter of a previous lesion \>1 cm in short axis;≥ 50% increase e in circulating plasma cells (minimum of 200 cells per μL) if this is the only measure of disease. |
| Secondary | Maximum Depth of Response | Up to 12 weeks | Maximum depth of response includes the summation of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR), and stringent complete response (sCR) based on IMWG criteria. Minimal response(MR): ≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%, if present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. PR, VGPR, CR, and sCR were defined above. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 12 weeks | CBR is defined as a partial response or better (≥PR) + minimal response (MR) rate based on International Myeloma Working Group (IMWG) criteria. |
| Secondary | Bone Marrow Minimal Residual Disease (MRD) Negativity | Up to 12 weeks | Bone marrow minimal residual disease (MRD) negativity will be defined as the ratio of subjects who achieved MRD to all subjects. MRD negativity will be assessed by next-generation sequencing with a minimum sensitivity of 1x10-5. |
| Secondary | Time to First Response | Up to 12 weeks | Time to first response is defined as the time from the first study treatment to the achievement of PR or better as defined by IMWG criteria. |
| Secondary | Time to Best Response | Up to 12 weeks | Time to best response is defined as the time from the first study treatment to the achievement of best response (PR, VGPR, CR, or sCR) based on IMWG criteria. |
| Secondary | Duration of Response | Up to 3 years | Duration of response is defined as the time from the achievement of PR or better until progressive disease (PD) based on IMWG criteria. Subjects will be censored if they die of anything other than myeloma. |
| Secondary | Progression-free Survival (PFS) | Up to 3 years | PFS is defined as the time from the first study treatment until confirmed PD based on IMWG criteria or death from any cause, whichever comes first. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05911321
GET https://conductscience.org/api/trials/v1/NCT05911321/registered