18 and older, any sex, with Multiple 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.
Median Progression-Free Survival (PFS)Primary· The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.
The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
8.5
6.2 – 10.8
Overall Response Rate (ORR)Secondary· The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Overall Response (OR) during the entire time on the study.
Overall Response Rate is the percentage of participants who achieve a PR or better over the course of the study but prior to initiation of subsequent anti-cancer therapy
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
56.8
44.7 – 68.2
Progression Free Survival (PFS) at Landmark Points - 20 MonthsSecondary· The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.
PFS at landmark points are the percentage of participants without progression (i.e., KM estimates) at the landmark time endpoints.
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
6.6
1.6 – 16.9
Duration of Response (DOR)Secondary· The median time on study was 19.6 months (range: 0.16+, 24.64).
The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of PD, death, or date of censoring for the participants not progressed/died. The censoring date is the last adequate tumor assessment date.
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
9.5
6.9 – 10.6
Overall Survival (OS) at 24 MonthsSecondary· The median time on study was 19.6 months (0.16+, 24.64), with the 24 month Overall Survival (OS) rate presented based on Kaplan-Meier estimates.
As the median overall survival has not been reached, the data for the landmark analysis at 24 months are provided.
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
53.6
38.0 – 67.0
Time to Progression (TTP)Secondary· The median time on study was 19.6 months (range: 0.16+, 24.64).
Time from date of first dose of study treatment to the date of first documented evidence of PD or date of censoring for the participants not progressed. The censoring date is the last adequate tumor assessment date.
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
10.6
7.8 – 12
Safety and Tolerability of Ibrutinib in Combination With Bortezomib and Dexamethasone as Measured by the Number of Participants With Adverse Events.Secondary· From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).
Safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone as measured by the frequency and type of adverse events graded using the NCI CTCAE v 4.03. Frequency and Type of Adverse Events are reported in the Adverse Events module
Group
Value
95% CI
Ibrutinib+ Bortezomib+ Dexamethasone
74
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period)..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ibrutinib+ Bortezomib+ Dexamethasone
Serious: 47/74 (64%)
Deaths: 27/74
Serious adverse events (66 terms)
Reaction
System
Ibrutinib+ Bortezomib+ Dex…
Pneumonia
Infections and infestations
—
Atrial fibrillation
Cardiac disorders
—
Sepsis
Infections and infestations
—
Spontaneous haematoma
Blood and lymphatic system disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Renal failure
Renal and urinary disorders
—
Hyponatraemia
Metabolism and nutrition disorders
—
Bronchitis
Infections and infestations
—
Lung infection
Infections and infestations
—
Pneumonia bacterial
Infections and infestations
—
Pneumonia haemophilus
Infections and infestations
—
Pneumonia pneumococcal
Infections and infestations
—
Upper respiratory tract infection
Infections and infestations
—
Circulatory collapse
Vascular disorders
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress
· Phase 2
· recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia
· Phase 1
· not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
Other Pharmacyclics Switzerland GmbH trials
Trials by the same sponsor.
NCT03229200 — Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
· Phase 4
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pharmacyclics Switzerland GmbH
Last refreshed: 16 March 2020
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/NCT02902965.