Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

Number of Patients With Overall Response (Complete Response + Partial Response)
Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg
Over 4 cycles (prior to the addition of dexamethasone)

Secondary Outcomes (1)

Number of Patients With Complete Response
Over 4 cycles (prior to the addition of dexamethasone)

Study Arms (2)

1

EXPERIMENTAL

VELCADE administered by subcutaneous injection

Drug: VELCADE Administered by subcutaneous injection

2

ACTIVE COMPARATOR

VELCADE administered by intravenous infusion

Drug: VELCADE Administered by intravenous infusion

Interventions

VELCADE Administered by subcutaneous injectionDrug

Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle

VELCADE Administered by intravenous infusionDrug

Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects 18 years or older
Diagnosis of multiple myeloma

Sponsors & Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industrycollaborator
Millennium Pharmaceuticals, Inc.
Industrylead

Study Sites (3)

UZ Brussel Department Medical Oncology Laarbeeklaan 101

Brussels, 1090, Belgium

Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU

Nantes, 44093, France

Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33

Münster, 48129, Germany

Related Publications (2)

Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Rekhtman G, Masliak Z, Robak P, Esseltine DL, Feng H, Deraedt W, van de Velde H, Arnulf B. Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study. Haematologica. 2015 May;100(5):e207-10. doi: 10.3324/haematol.2014.118182. Epub 2015 Jan 16. No abstract available.
PMID: 25596270DERIVED
Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18.
PMID: 21507715

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title: Helgi Van de Velde, M.D., Ph.D.
Organization: Johnson & Johnson Pharmaceutical Research & Development

Study Officials

Medical Monitor
Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

222 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

July 2008

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations