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.

Tracking Information

• First Submitted Date: July 23, 2008
• First Posted Date: July 25, 2008
• Results First Submitted Date: August 30, 2011
• Results First Posted Date: October 4, 2011
• Last Update Posted Date: October 10, 2011
• Study Start Date: July 2008
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2011)

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

• Original Primary Outcome Measures (submitted: July 24, 2008): Overall response rate [ Time Frame: After 4 cycles (prior to the addition of dexamethasone) ]

Current Secondary Outcome Measures (submitted: October 6, 2011)

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.

• Original Secondary Outcome Measures (submitted: July 24, 2008): Complete response, near complete response, and very good partial response [ Time Frame: After 4 cycles ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
• Official Title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• 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
• 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.

Study Arms

• Experimental: 1
  VELCADE administered by subcutaneous injection
  Intervention: Drug: VELCADE Administered by subcutaneous injection
• Active Comparator: 2
  VELCADE administered by intravenous infusion
  Intervention: Drug: VELCADE Administered by intravenous infusion

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 30, 2011): 222
• Original Estimated Enrollment (submitted: July 24, 2008): 192
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00722566
• Other Study ID Numbers: 26866138 MMY 3021
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Millennium Pharmaceuticals, Inc.
• Original Responsible Party: Clinical Research Monitor, Johnson & Johnson Pharmaceutical Research & Development
• Current Study Sponsor: Millennium Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: 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.

• PRS Account: Millennium Pharmaceuticals, Inc.
• Verification Date: October 2011