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NCT00722566: Phase 3: A Study of Subcutaneous and Intravenous VELCADE in Patients With RRMM

Updated: Apr 26

NCT00722566: Phase 3: A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma


velcade

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma


Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion


Sponsor:

Millennium Pharmaceuticals, Inc.


Collaborator:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


ClinicalTrials.gov Identifier: NCT00722566


Official Title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

First Posted : July 25, 2008


Click here to see details on ClinicalTrials.gov

 

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

 

Drug: VELCADE Administered by subcutaneous injection

Drug: VELCADE Administered by intravenous infusion

 

Haematologica; 2015

Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study


https://pubmed.ncbi.nlm.nih.gov/25596270/



 

Haematologica; 2012

Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma


Abstract

The phase III MMY-3021 study compared safety and efficacy of subcutaneous versus intravenous administration of the proteasome inhibitor bortezomib in patients with relapsed myeloma. The initial report demonstrated non-inferior efficacy with subcutaneous versus intravenous bortezomib for the primary end point: overall response rate after four cycles of single-agent bortezomib. We report updated outcome analyses after prolonged follow up. Best response rate (after up to ten cycles of bortezomib ± dexamethasone) remained 52% in each arm, including 23% and 22% complete or near-complete responses with subcutaneous and intravenous bortezomib, respectively. Time to progression (median 9.7 vs. 9.6 months; hazard ratio 0.872, P=0.462), progression-free survival (median 9.3 vs. 8.4 months; hazard ratio 0.846, P=0.319), and overall survival (1-year: 76.4% vs. 78.0%, P=0.788) were comparable with subcutaneous versus intravenous bortezomib. Peripheral neuropathy rates remained significantly lower with subcutaneous versus intravenous bortezomib, with increased rates of improvement/resolution at the time of this analysis.

https://pubmed.ncbi.nlm.nih.gov/22689676/

 

Lancet Oncol; 2011

Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study


Interpretation: Subcutaneous bortezomib offers non-inferior efficacy to standard intravenous administration, with an improved safety profile.

https://pubmed.ncbi.nlm.nih.gov/21507715/

 



Locations


Belgium

France

Germany




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