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

NCT00722566 | Completed Phase 3 Results

• 1 other identifier: 26866138 MMY 3021
• Study Type: interventional
• Target: 222
• Locations: 3 countries
• Sites: 3

Brief Summary

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

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 injection DRUG

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

1

VELCADE Administered by intravenous infusion DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 years or older
• Diagnosis of multiple myeloma
• Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr
• Relapse or progression of myeloma following prior systemic antineoplastic therapy.

You may not qualify if:

• Previous treatment with VELCADE
• More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
• Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
• Any of the following within 3 weeks prior to randomization:
• antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
• Any of the following within 2 weeks prior to randomization:
• radiation therapy, major surgery (kyphoplasty is not considered major surgery)
• Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (3)

UZ Brussel Department Medical Oncology Laarbeeklaan 101

Brussels, 1090, Belgium

Location

Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU

Nantes, 44093, France

Location

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

Münster, 48129, Germany

Location

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: 25596270 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

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

HVDVELDE@ITS.JNJ.COM

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

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 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 10, 2011
• Results First Posted: October 4, 2011

Record last verified: 2011-10

Locations

DE (1); BE (1); FR (1)