Trial · NCT02547662
Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
NCT02547662, Phase 2, Completed, Mayo Clinic; results first posted 2022-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia. Trials, record NCT02547662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02547662
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
- NCT number
- NCT02547662
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Plasma Cell Leukemia, Plasma Cell Myeloma, Plasmacytoma
- Interventions
- Dexamethasone, Ixazomib Citrate, Laboratory Biomarker Analysis, Pomalidomide
- First posted
- 2015-09-11
- Last updated
- 2023-10-30
- Results first posted
- 2022-05-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Response Rate | 4 years | A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Biochemical Response Rate | 4 years | The biochemical response rate will be estimated by the number of responders(patients that achieved partial or complete response) divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated. |
| Secondary | Extramedullary Response Rate | 4 years | Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters. The extramedullary response rate will be estimated by the number of responders(patients that achieved a partial or complete response) divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated. |
| Secondary | Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | 4 years 1 month | Number of patients with adverse events is reported here, the full list of those adverse events and their frequency is reported in the adverse event section. |
| Secondary | Progression-free Survival | 4 years 8 months | The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. |
| Other | Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status | Up to 5 years | The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve a sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Response Rate | 4 years | proportion of patients | NUMBER | |
| SECONDARY | Biochemical Response Rate | 4 years | All patients evaluated for biochemical response | proportion of participants | NUMBER |
| SECONDARY | Extramedullary Response Rate | 4 years | All patients with extramedullary disease that were evaluated for response. | proportion of participants | NUMBER |
| SECONDARY | Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | 4 years 1 month | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival | 4 years 8 months | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status | Up to 5 years |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Response Rate | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.06 | 95% Confidence Interval 0.0 to 0.29 | proportion of patients | |
| Biochemical Response Rate | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.25 | 95% Confidence Interval 0.05 to 0.57 | proportion of participants | |
| Extramedullary Response Rate | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.40 | 95% Confidence Interval 0.05 to 0.85 | proportion of participants | |
| Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 17 | Participants | ||
| Progression-free Survival | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 4.5 | 95% Confidence Interval 2.0 to 11.8 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 17 | |
| Overall Study | COMPLETED | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 17 | |
| Overall Study | NOT COMPLETED | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0 |
Source ClinicalTrials.gov
Adverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 16 | 17 | 47 |
| other | Eye disorders - Other, specify | Eye disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 1 | 17 | 6 |
| other | Constipation | Gastrointestinal disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 10 | 17 | 55 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 5 | 17 | 6 |
| other | Nausea | Gastrointestinal disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 9 | 17 | 13 |
| other | Edema limbs | General disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 2 | 17 | 3 |
| other | Fatigue | General disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 14 | 17 | 102 |
| other | Pain | General disorders | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 1 | 17 | 1 |
| other | Urinary tract infection | Infections and infestations | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 1 | 17 | 1 |
| other | Ankle fracture | Injury, poisoning and procedural complications | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 1 | 17 | 4 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 3 | 17 |
| Total, other adverse events | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 17 | 17 |
| Total, serious adverse events | Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 5 | 17 |
Source ClinicalTrials.gov
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/NCT02547662
GET https://conductscience.org/api/trials/v1/NCT02547662/events?page=2