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

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00722566

First received: July 23, 2008

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Results First Received: August 30, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Myeloma
Interventions:	Drug: VELCADE Administered by subcutaneous injection Drug: VELCADE Administered by intravenous infusion

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
VELCADE Subcutaneous	VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
VELCADE Intravenous	VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.

Participant Flow: Overall Study

	VELCADE Subcutaneous	VELCADE Intravenous
STARTED	148 ^[1]	74
COMPLETED	81 ^[2]	39 ^[2]
NOT COMPLETED	67	35

[1]	One patient randomized and not dosed
[2]	Completed 8 cycles

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
VELCADE Subcutaneous	VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
VELCADE Intravenous	VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
Total	Total of all reporting groups

Baseline Measures

	VELCADE Subcutaneous	VELCADE Intravenous	Total
Number of Participants [units: participants]	148	74	222
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	74	37	111
>=65 years	74	37	111
Age [units: years] Mean (Standard Deviation)	64.3 (8.96)	64.0 (12.11)	64.2 (10.09)
Gender [units: participants]
Female	74	27	101
Male	74	47	121
Region of Enrollment [units: participants]
France	22	14	36
Belgium	7	5	12
Germany	2	4	6
Netherlands	6	4	10
United Kingdom	6	3	9
Ukraine	51	17	68
Russian Federation	26	9	35
Poland	20	7	27
Argentina	5	8	13
India	3	3	6

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Helgi Van de Velde, M.D., Ph.D.
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: HVDVELDE@ITS.JNJ.COM

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.

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 History of Changes
Other Study ID Numbers:	26866138 MMY 3021
Study First Received:	July 23, 2008
Results First Received:	August 30, 2011
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

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