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NCT02547662

Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia

Completed Phase 2 Results posted Last updated 30 October 2023
What this trial tests

Phase 2 trial testing Dexamethasone in Plasma Cell Leukemia in 17 participants. Completed in 30 October 2020.

Timeline
24 December 2015
Primary endpoint
30 October 2020
30 October 2020

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment17
Start date24 December 2015
Primary completion30 October 2020
Estimated completion30 October 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Plasma Cell Leukemia or Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Confirmed Response Rate Primary · 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), Disapp

GroupValue95% CI
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)0.060.0 – 0.29
Biochemical Response Rate Secondary · 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.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)0.250.05 – 0.57
Extramedullary Response Rate Secondary · 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.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)0.400.05 – 0.85
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Secondary · 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.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)17
Progression-free Survival Secondary · 4 years 8 months

The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)4.52.0 – 11.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were followed for 4 years and 1 month, mortality was followed for 4 years and 8 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
Serious: 5/17 (29%)
Deaths: 3/17

Serious adverse events (23 terms)

ReactionSystemTreatment (Ixazomib Citrat…
Lung infectionInfections and infestations
Platelet count decreasedInvestigations
ConfusionPsychiatric disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
AnemiaBlood and lymphatic system disorders
Death NOSGeneral disorders
Infections and infestations - Oth specInfections and infestations
Upper respiratory infectionInfections and infestations
Ankle fractureInjury, poisoning and procedural complications
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Creatinine increasedInvestigations
Lymphocyte count decreasedInvestigations
Back painMusculoskeletal and connective tissue disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
Neck painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Neoplasms benign, mal, uncpec - Oth specNeoplasms benign, malignant and unspecified (incl cysts and polyps)
EncephalopathyNervous system disorders
Intracranial hemorrhageNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
Other adverse events (22 terms — click to expand)

ReactionSystemTreatment (Ixazomib Citrat…
AnemiaBlood and lymphatic system disorders
FatigueGeneral disorders
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations
Platelet count decreasedInvestigations
ConstipationGastrointestinal disorders
Peripheral sensory neuropathyNervous system disorders
NauseaGastrointestinal disorders
Creatinine increasedInvestigations
DiarrheaGastrointestinal disorders
Lymphocyte count decreasedInvestigations
Edema limbsGeneral disorders
Peripheral motor neuropathyNervous system disorders
Eye disorders - Other, specifyEye disorders
PainGeneral disorders
Urinary tract infectionInfections and infestations
Ankle fractureInjury, poisoning and procedural complications
HyperglycemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
TremorNervous system disorders
Rash maculo-papularSkin and subcutaneous tissue disorders

Most-reported serious reactions: Lung infection, Platelet count decreased, Confusion, Hypoxia, Anemia, Death NOS, Infections and infestations - Oth spec, Upper respiratory infection.

Data from ClinicalTrials.gov NCT02547662 adverse events section.

Sponsor's own description

This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Spotlight on ixazomib: potential in the treatment of multiple myeloma.
    Muz B, Ghazarian RN, Ou M, Luderer MJ, et al · · 2016 · cited 87× · PMID 26811670 · DOI 10.2147/dddt.s93602
  2. Plasma Cell Leukemia: Definition, Presentation, and Treatment.
    Gundesen MT, Lund T, Moeller HEH, Abildgaard N. · · 2019 · cited 67× · PMID 30689121 · DOI 10.1007/s11912-019-0754-x
  3. A clinical perspective on plasma cell leukemia; current status and future directions.
    Tuazon SA, Holmberg LA, Nadeem O, Richardson PG. · · 2021 · cited 45× · PMID 33563906 · DOI 10.1038/s41408-021-00414-6
  4. Update on primary plasma cell leukemia.
    Jung SH, Lee JJ. · · 2022 · cited 14× · PMID 35483928 · DOI 10.5045/br.2022.2022033
  5. Ikaros Proteins in Tumor: Current Perspectives and New Developments.
    Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
  6. Plasma Cell Leukemia - Facts and Controversies: More Questions than Answers?
    Suska A, Vesole DH, Castillo JJ, Kumar SK, et al · · 2020 · cited 10× · PMID 34595454 · DOI 10.2991/chi.k.200706.002
  7. Management of Primary Plasma Cell Leukemia Remains Challenging Even in the Era of Novel Agents.
    Chaulagain CP, Diacovo MJ, Van A, Martinez F, et al · · 2021 · cited 10× · PMID 33716516 · DOI 10.1177/2634853521999389

Verify or expand the search:

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02547662.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing