Trial · NCT05392946
Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
NCT05392946, Phase 1, Phase 2, Active not recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study. Trials, record NCT05392946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05392946
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
- NCT number
- NCT05392946
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Plasma Cell Myeloma
- Interventions
- Bortezomib, Daratumumab, Dexamethasone, Iberdomide
- First posted
- 2022-05-26
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of iberdomide (Phase I) | Up to 12 cycles. Each cycle is 28 days. | MTD is defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose limiting toxicity definitions. |
| Primary | Complete response rate (Phase II) | Up to 3 years | A confirmed complete response is defined as a patient who has achieved an stringent complete response (sCR) or complete response (CR) and maintained it on two consecutive evaluations at any time during induction therapy. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Overall response rate (Phase II) | Up to 3 years | Will be estimated by the total number of patients who achieve a sCR, CR, very good partial response (VGPR), or partial response divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. |
| Secondary | VGPR or better response rate (Phase II) | Up to 3 years | Will be estimated by the total number of patients who achieve at least a VGPR divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true VGPR or better response rate will be calculated. |
| Secondary | Progression-free survival (Phase II) | Up to 3 years | Assessed as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Overall survival (Phase II) | Up to 3 years | Assessed as from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Incidence of adverse events (AEs) (Phase II) | Up to 30 days after discontinuation | The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. |
| Secondary | Proportion of patients with measurable residual disease (MRD) negative complete response (Phase II) | At the end of cycles 24 and 36. Each cycle is 28 days | The proportion of patients who achieve MRD negative complete response at the end of cycles 24 and 36 will be estimated by the number of patients who are MRD negative (as measured by the next-generation flow cytometry, sensitivity 10-5) at the end of end of cycles 24 and 36 divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true MRD negative rates end of cycles 24 and 36 of therapy will be calculated. |
| Other | Minimal residual disease | Up to 3 years | Will be assessed on bone marrow aspirate in all patients achieving sCR or CR. The proportion of patients who achieve MRD negative status following induction will be estimated by the number of patients who are MRD negative at the end of induction divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true MRD negative rate after induction will be calculated. |
| Other | Proportion of patients who achieve sustained MRD negative status | At the end of cycles 24 and 36. Each cycle is 28 days. | Will be estimated by the number of patients who are MRD negative at the end of end of cycles 24 and 36 divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true MRD negative rates end of cycles 24 and 36 of therapy will be calculated. |
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 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/NCT05392946
GET https://conductscience.org/api/trials/v1/NCT05392946/registered