Trial · NCT06517017
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
NCT06517017, Phase 2, Recruiting, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma. Trials, record NCT06517017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06517017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
- NCT number
- NCT06517017
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of Utah
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Interventions
- Isatuximab
- First posted
- 2024-07-24
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Completion rate of 9 cycles of treatment | At the end of 9 cycles of treatment (each cycle is 28 days) | Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma |
| Secondary | Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain | At the end of 4 cycles of treatment (each cycle is 28 days) | Assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the EORTC score. The questionnaire has 10 subscales, each with a score range of 0 to 100 points. Higher scores on the functional scales and global quality of life indicate better functioning, while higher scores on the symptom scales indicate a higher symptom burden. The QLQ-C30 summary score is calculated by averaging the scores of the 13 scales and items, with a higher score indicating a better health-related quality of life (HRQoL). |
| Secondary | Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type | At study completion. Participants will be enrolled in study for about 3 years. | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. |
| Secondary | Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0) | At study completion. Participants will be enrolled in study for about 3 years. | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. |
| Secondary | Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness | At study completion. Participants will be enrolled in study for about 3 years. | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. |
| Secondary | Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration | At study completion. Participants will be enrolled in study for about 3 years. | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. |
| Secondary | Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment | At study completion. Participants will be enrolled in study for about 3 years. | Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population. |
| Secondary | Overall survival (OS) | Time from registration until 3 years from start of therapy or death from any cause. | Assess overall survival in this study population |
Source ClinicalTrials.gov
Outcomes0
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/NCT06517017
GET https://conductscience.org/api/trials/v1/NCT06517017/registered