Trial · NCT04776395
Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
NCT04776395, Phase 2, Recruiting, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma. Trials, record NCT04776395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04776395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
- NCT number
- NCT04776395
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 68 participants, estimated
- Lead sponsor
- Emory University
- Conditions
- Smoldering Plasma Cell Myeloma
- Interventions
- Dexamethasone, Iberdomide Hydrochloride, Quality-of-Life Assessment
- First posted
- 2021-03-01
- Last updated
- 2026-06-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate | Up to 3 years | Assessed per International Myeloma Working Group response criteria (to be done with serum and urine immunologic studies monthly; bone marrow biopsy and repeat imaging at either complete response or progressive disease). |
| Secondary | Progression-free survival | From start of protocol therapy to disease progression or death from any cause, whichever comes first, assessed at 1 and 2 years | Will be estimated with the Kaplan-Meier method with 95% confidence interval (CI) for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported. |
| Secondary | Time to progression | From start of protocol therapy to disease progression, assessed at 1 and 2 years | Will be estimated with the Kaplan-Meier method with 95% CI for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported. |
| Secondary | Overall survival | From start of protocol therapy to death, censoring patients who are alive at last follow-up, assessed at 1 and 2 years | Will be estimated with the Kaplan-Meier method with 95% CI for the two randomized arms separately and combined. Cox proportional hazards models will be further used to compare the two randomized arm with hazard ratio and its 95% CI reported. |
| Secondary | Rate of grade 3-4 adverse events | Up to 30 days after the last day of study participation | Adverse event data will be described and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events guidelines. Grade 3-4 adverse events will be estimated as frequency and percentage, and then compared between the two patient groups using Chi-Square test. |
| Secondary | Successful stem cell mobilization | Up to 3 years | Defined as collection of 3.5 x 10\^6 CD34 cells per kilogram weight. |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 to 2025 |
Source NIH RePORTER
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/NCT04776395
GET https://conductscience.org/api/trials/v1/NCT04776395/registered