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NCT00570180

Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

Completed Phase 2 Last updated 1 September 2020
What this trial tests

Phase 2 trial testing Bortezomib in Multiple Myeloma in 36 participants. Completed in 15 September 2015.

Timeline
25 August 2008
Primary endpoint
15 September 2015
15 September 2015

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date25 August 2008
Primary completion15 September 2015
Estimated completion15 September 2015
Sites7 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression.

Publications & conference data

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

  1. Toward personalized treatment in multiple myeloma based on molecular characteristics.
    Pawlyn C, Davies FE. · · 2019 · cited 149× · PMID 30587529 · DOI 10.1182/blood-2018-09-825331
  2. Gene Expression Profiling in Multiple Myeloma: Redefining the Paradigm of Risk-Adapted Treatment.
    Cerchione C, Usmani SZ, Stewart AK, Kaiser M, et al · · 2022 · cited 13× · PMID 35211412 · DOI 10.3389/fonc.2022.820768

Verify or expand the search:

Other trials of Bortezomib

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other University Health Network, Toronto trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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