Trial · NCT06050512
Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
NCT06050512, Phase 1, Phase 2, Withdrawn, Kathleen Dorritie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma. Trials, record NCT06050512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06050512
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
- NCT number
- NCT06050512
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Kathleen Dorritie
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Interventions
- Mezigdomide, Ixazomib, Dexamethasone
- First posted
- 2023-09-22
- Last updated
- 2024-11-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase l: Recommended Phase II Dose (RP2D) | Up to 17 months | Dose-limiting toxicity (DLT) per adverse events as defined using National Cancer Institute (NCI) CTCAE v5.0. Hematologic DLTs: Grade 4 neutropenia \< 500/μL for more than 5 days, Grade 3 neutropenia with fever \> 38.3°C (one time) or fever \> 38.0°C sustained for one hour, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding; Non-Hematologic DLTs: Grade 3 diarrhea lasting \>3 days (not recovering to \< grade 2) despite supportive care, Grade 3 nausea or vomiting \>3 days (not recovering to \< grade 2) days despite supportive care, Grade 3 fatigue lasting \>7 days (not recovering to \< grade 2) days despite supportive care, Grade 4 diarrhea, Grade 4 nausea or vomiting, Allergic reaction or hypersensitivity if unable to be corrected to \<grade 1 within 48 hours, Any other non-hematologic grade \>3 toxicity for which there is not a clear alternative explanation; General: dose modification or delay of mezigdomide or ixazomib during cycle 1 due to treatment related toxicity. |
| Primary | Phase ll: Overall Response Rate (ORR) | Up to 36 months | Preliminary efficacy of mezigdomide when given in combination with ixazomib and dexamethasone as estimated by ORR, as defined by the International Myeloma Working Group (IMWG) response criteria. This will be expressed as the proportion of patients who achieve complete response (CR) or partial response (PR). CR is defined as negative serum and urine M-protein immunofixation (IF), along with the presence of \< 5% plasma cells (PCs) in bone marrow (BM) biopsy. PR is defined as ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours. |
| Secondary | Incidence and severity of Adverse Events | Up to 36 months | Incidence and severity of adverse events AEs, as defined by the NCI-Common Terminology Criteria for Adverse Events v5.0, tabulated by type, grade and relatedness to treatment for each dose level achieved in the study and overall. |
| Secondary | Depth of Response | Up to 36 months | Depth of Response will be measured as the proportion of participants in each category, given IMWG Uniform Response Criteria at each dose level and overall. |
| Secondary | Duration of Response (DOR) | Up to 36 months | The time from the date of the earliest documented response (PR, VGPR, CR or sCR) to the earliest date of disease progression or death, whichever occurred first. Disease progression will be determined by the investigator per IMWG Uniform Response Criteria. |
| Secondary | Progression-free Survival (PFS) | Up to 36 months | The time from the date of first treatment to the earliest date of disease progression or death, whichever occurred first. Disease progression will be determined by the investigator per IMWG Uniform Response Criteria. |
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/NCT06050512
GET https://conductscience.org/api/trials/v1/NCT06050512/registered