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

• ClinicalTrials.gov Identifier: NCT00722566
• Recruitment Status: Completed
• First Posted: July 25, 2008
• Results First Posted: October 4, 2011
• Last Update Posted: October 10, 2011
• Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Information provided by (Responsible Party): Millennium Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: VELCADE Administered by subcutaneous injection; Drug: VELCADE Administered by intravenous infusion	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma
• Study Start Date: July 2008
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; VELCADE administered by subcutaneous injection	Drug: VELCADE Administered by subcutaneous injection; Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
Active Comparator: 2; VELCADE administered by intravenous infusion	Drug: VELCADE Administered by intravenous infusion; Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Overall Response (Complete Response + Partial Response) [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ]

   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

Secondary Outcome Measures :

1. Number of Patients With Complete Response [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female subjects 18 years or older
2. Diagnosis of multiple myeloma
3. 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
4. Relapse or progression of myeloma following prior systemic antineoplastic therapy.

Exclusion Criteria:

1. Previous treatment with VELCADE
2. 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)
3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2

4. 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

5. Any of the following within 2 weeks prior to randomization:

   radiation therapy, major surgery (kyphoplasty is not considered major surgery)

6. 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

Contacts and Locations

Locations

Belgium

UZ Brussel Department Medical Oncology Laarbeeklaan 101

Brussel, Belgium, 1090

France

Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU

NANTES Cedex 01, France, 44093

Germany

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

Münster, Germany, 48129

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

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

Investigators

• Study Director: Medical Monitor; Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Erratum In: Lancet Oncol. 2011 Jun;12(6):522.

• Responsible Party: Millennium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00722566
• Other Study ID Numbers: 26866138 MMY 3021
• First Posted: July 25, 2008
• Results First Posted: October 4, 2011
• Last Update Posted: October 10, 2011
• Last Verified: October 2011

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bortezomib; Antineoplastic Agents