Trial · NCT05183139
A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
NCT05183139, Phase 4, Withdrawn, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma. Trials, record NCT05183139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05183139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT05183139
- Status
- Withdrawn
- Phases
- Phase 4
- Enrollment
- 0 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Multiple Myeloma
- Interventions
- Ixazomib, Pomalidomide, Lenalidomide, Dexamethasone
- First posted
- 2022-01-10
- Last updated
- 2022-05-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Up to approximately 5 years | PFS is defined as the time from the date of the first administration of the study drug regimen ixazomib with pomalidomide and dexamethasone or ixazomib with lenalidomide and dexamethasone (IPd/IRd) to the date of the first documentation of disease progression before the start of next line of therapy based on local laboratory results and the investigator's assessment using modified International Myeloma Working Group (IMWG) response criteria or death due to any cause, whichever occurs first. |
| Secondary | Percentage of Participants Maintaining or Achieving PR, Very Good Partial Response (VGPR), or Complete Response (CR) | Up to approximately 5 years | Percentage of participants with PR, VGPR, and CR will be determined based on local laboratory results and investigator's assessment using modified IMWG response criteria. CR: No immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow. Participants with measurable disease only by serum free light chain (SFLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria required. VGPR: Serum/urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% decrease in serum M-protein with urine M-protein \<100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, ≥90% decrease in difference between involved and uninvolved free light chain (dFLC) levels in addition to VGPR criteria required. PR: ≥50% reduction of serum M-protein and ≥90% reduction in urine M-protein or to \<200 mg/24 hrs, or a ≥50% decrease in dFLC. If present at Baseline, ≥50% reduction in size of soft tissue plasmacytomas required. |
| Secondary | Time to Progression (TTP) | Up to approximately 5 years | TTP is defined as the time from the date of the first administration of the study drug regimen (IPd/IRd) to the date of the first documentation of disease progression based on local laboratory results and the investigator's assessment using modified IMWG response criteria. |
| Secondary | Duration of Therapy (DoT 1) | Up to approximately 5 years | DoT 1 is defined as the date of the first administration of the parenteral PI-based regimen to the date of the last administration of any of the three drugs in the study drug regimen. |
| Secondary | Duration of Therapy (DoT 2) | Up to approximately 5 years | DoT 2 is defined as the time from the date of the first administration of the study drug regimen (IPd or IRd) to the date of the last administration of any of the three drugs in the study drug regimen. |
| Secondary | Duration of PI Therapy | Up to approximately 5 years | Duration of parenteral PI therapy is defined as the time from the date of the first administration of the parenteral PI therapy of the regimen preceding the study drug regimen (IPd or IRd) to the date of the last administration of ixazomib therapy |
| Secondary | Duration of Ixazomib Therapy | Up to approximately 5 years | Duration of ixazomib therapy is defined as the time from the date of the first administration of ixazomib to the date of the last administration of ixazomib therapy. |
| Secondary | Relative Dose Intensity (RDI) for Each Drug in the Treatment Regimen | Up to approximately 5 years | RDI for each drug in the study drug regimen (IPd/IRd) is defined as 100 × (Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals (dose prescribed at enrollment) × number of prescribed doses per cycle × the number of treated cycles. |
| Secondary | Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Up to approximately 5 years | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
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/NCT05183139
GET https://conductscience.org/api/trials/v1/NCT05183139/registered