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.
Progression Free Survival by Independent Response Adjudication Committee (IRAC)Primary· From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.
Progressive Disease is defined as an Increase of ≥ 25% from nadir in:
* Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g
* Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)
* In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be \> 100 mg/dL.
* Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h
* Definite deve
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
11.20
9.66 – 13.73
Treatment 2: BTZ+LD-DEX
7.10
5.88 – 8.48
Overall Survival (OS)Secondary· From randomization to date of death, up to approximately 65 months
Overall survival (OS) is calculated as the time from randomization to death from any cause.
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
35.58
28.55 – 41.20
Treatment 2: BTZ+LD-DEX
31.61
26.05 – 37.16
Overall Response Rate by Independent Response Adjudication Committee (IRAC)Secondary· From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
The ORR together with the relative proportions in each response category (ie, stringent CR \[sCR\], CR, very good PR \[VGPR\], PR, SD, and PD) by treatment using the IMWG criteria will be examined.
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-pro
Stringent complete response
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
9
Treatment 2: BTZ+LD-DEX
2
Complete Reponse
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
35
Treatment 2: BTZ+LD-DEX
9
Very Good Partial Response
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
104
Treatment 2: BTZ+LD-DEX
40
Partial Response
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
83
Treatment 2: BTZ+LD-DEX
88
Stable Disease
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
32
Treatment 2: BTZ+LD-DEX
106
Progressive Disease
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
11
Treatment 2: BTZ+LD-DEX
16
Not Evaluable
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
7
Treatment 2: BTZ+LD-DEX
17
Duration of Response by Independent Response Adjudication Committee (IRAC)Secondary· From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR: Serum and urine M-protein detectable by immunofixation
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
13.70
10.94 – 18.10
Treatment 2: BTZ+LD-DEX
10.94
8.11 – 14.78
Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)Secondary· From first dose to 28 days after the last dose (up to approximately 44 months
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
259
Treatment 2: BTZ+LD-DEX
194
Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)Secondary· From first dose to 28 days after the last dose (up to approximately 44 months
Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Group
Value
95% CI
Treatment 1: POM+BTZ+LD-DEX
29
Treatment 2: BTZ+LD-DEX
12
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment 1: POM + BTZ + LD-DEX
Serious: 177/278 (64%)
Deaths: 197/281
Treatment 2: BTZ + LD-DEX
Serious: 119/270 (44%)
Deaths: 193/278
Serious adverse events (277 terms)
Reaction
System
Treatment 1: POM + BTZ + L…
Treatment 2: BTZ + LD-DEX
Pneumonia
Infections and infestations
—
—
Pyrexia
General disorders
—
—
Influenza
Infections and infestations
—
—
Lower respiratory tract infection
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
General physical health deterioration
General disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Septic shock
Infections and infestations
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Syncope
Nervous system disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Respiratory tract infection
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Death
General disorders
—
—
Clostridium difficile colitis
Infections and infestations
—
—
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07463807 — Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carf
· Phase 1, PHASE2
· not yet recruiting
NCT06948084 — Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Darat
· Phase 2
· not yet recruiting
NCT07523737 — Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Dif
· Phase 2
· recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi
· Phase 3
· recruiting
NCT07096778 — Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
· Phase 2
· 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 Celgene trials
Trials by the same sponsor.
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· Phase 1
· recruiting
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· Phase 1, PHASE2
· recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch
· Phase 3
· recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W
· Phase 2
· recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Celgene
Last refreshed: 6 June 2023
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/NCT01734928.