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NCT03506360

Pembrolizumab, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Completed Phase 2 Results posted Last updated 9 January 2024
What this trial tests

Phase 2 trial testing Dexamethasone in Recurrent Plasma Cell Myeloma in 13 participants. Completed in 10 December 2020.

Timeline
19 June 2018
Primary endpoint
14 November 2019
10 December 2020

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date19 June 2018
Primary completion14 November 2019
Estimated completion10 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Recurrent 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.

Overall Response Percentage Primary · Up to 9 months

Defined as a partial response or better noted as the objective status on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)0.0770.004 – 0.322
>= Very Good Partial Response (VGPR) Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone Secondary · Up to 9 months

Will be estimated by the number of patients who achieve a VGPR, complete response (CR), or stringent complete response (sCR) at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)0NA – NA
Complete Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone Secondary · Up to 2 years

Will be estimated by the number of patients who achieve a CR or sCR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)0NA – NA
Survival Time Secondary · Up to 2 years

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

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)93 – NA
Progression-free Survival Secondary · Up to 2 years

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

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)1.60.7 – 2.8
Incidence of Adverse Events Secondary · Up to 9 months

Graded according National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

GroupValue95% CI
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)13

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)
Serious: 1/13 (8%)
Deaths: 6/13

Serious adverse events (1 terms)

ReactionSystemTreatment (Ixazomib Citrat…
Gastrointestinal disorders - Oth specGastrointestinal disorders
Other adverse events (14 terms — click to expand)

ReactionSystemTreatment (Ixazomib Citrat…
FatigueGeneral disorders
Platelet count decreasedInvestigations
Creatinine increasedInvestigations
AnemiaBlood and lymphatic system disorders
ConstipationGastrointestinal disorders
Lymphocyte count decreasedInvestigations
NauseaGastrointestinal disorders
DiarrheaGastrointestinal disorders
Neutrophil count decreasedInvestigations
Lymphocyte count increasedInvestigations
Rash maculo-papularSkin and subcutaneous tissue disorders
VomitingGastrointestinal disorders
White blood cell decreasedInvestigations
HyperglycemiaMetabolism and nutrition disorders

Most-reported serious reactions: Gastrointestinal disorders - Oth spec.

Data from ClinicalTrials.gov NCT03506360 adverse events section.

Sponsor's own description

This phase II trial studies how well pembrolizumab works when given together with ixazomib citrate and dexamethasone in treating patients with multiple myeloma that has come back (relapsed). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with ixazomib citrate and dexamethasone may work better in treating patients with multiple myeloma.

Publications & conference data

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

  1. Update on PD-1/PD-L1 Inhibitors in Multiple Myeloma.
    Jelinek T, Paiva B, Hajek R. · · 2018 · cited 82× · PMID 30505301 · DOI 10.3389/fimmu.2018.02431
  2. Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
    Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924
  3. Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.
    Abramson HN. · · 2023 · cited 16× · PMID 37958658 · DOI 10.3390/ijms242115674

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

Other recruiting trials for Recurrent Plasma Cell Myeloma

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03506360.

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