A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

Sponsor

Millennium Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00063726

Collaborator

(none)

600

Enrollment

Locations

Duration (Months)

7.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: bortezomib	Phase 3

Detailed Description

The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patient experienced PD, as defined by SWOG+ criteria during or after treatment with high-dose dexamethasone in MPI Study M34101-039, but has not received alternate anti-neoplastic therapy. Intolerance to high-dose dexamethasone therapy as administered in MPI study M34101-039 does not qualify as PD.
Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from Screening through the End of Treatment visit.
Male patient agrees to use an acceptable barrier method for contraception from Screening through the End of Treatment visit.
Patient meets the following pretreatment laboratory criteria at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration). (Note that the End of Treatment assessments of MPI study M34101-039 may qualify as the Screening assessments for MPI study M34101-040 if performed within 14 days of the Baseline visit.):
Platelet count ≥20 X 10E+9/L, with or without transfusion support.
Hemoglobin ≥7.0 g/dL, with or without transfusion support.
Absolute neutrophil count (ANC)≥0.5 x 10E+9/L, without growth factor support.
Serum calcium <14 mg/dL (3.5 mmol/L).
Aspartate transaminase (AST):≤2.5 x the upper limit of normal (ULN).
Alanine transaminase (ALT):≤2.5 x the ULN.
Total bilirubin:≤1.5 x the ULN.
If calculated or measured creatinine clearance: ≥20 mL/minute, assessments are as specified in the protocol. If calculated or measured creatinine clearance is <20 mL/minute.

Exclusion Criteria

Patient participated in M34101-039 and did not have confirmed PD. Dexamethasone intolerance does not qualify as PD.
Patient had PD on the dexamethasone arm of the MPI Study M34101-039, and then received alternate anti-neoplastic therapy.
Patient has not recovered from dexamethasone-related toxicity experienced during MPI Study M34101-039.
Patient is known to be human immunodeficiency virus (HIV)-positive.(Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations.)
Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.(Patients assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local regulations.)
Female patient is pregnant or breast-feeding.
Patient developed a new or experienced worsening of an existing illness during or after completion of Study M34101-039 that, in the investigator's opinion, may put the patient at risk of participation in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas Medical Sciences	Little Rock	Arkansas	United States	72205
2	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
3	City of Hope	Duarte	California	United States	91010
4	Scripps Clinic, Green Cancer Center	La Jolla	California	United States	92307
5	Loma Linda University Medical Center	Loma Linda	California	United States	92354
6	Kaiser Permanente Medical Center	Vallejo	California	United States	94589
7	Lombardi Cancer Center, Georgetown University Medical Center	Washington	District of Columbia	United States	20007
8	Med Star Institute	Washington	District of Columbia	United States	20010
9	Hematology/Oncology Associates, PA	Jacksonville	Florida	United States	32207
10	University of Miami	Miami	Florida	United States	33136
11	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
12	Emory University	Atlanta	Georgia	United States	30322
13	Northwestern University Medical School	Chicago,	Illinois	United States	60611
14	Loyola University Medical Center: Cardinal Bernardin Cancer Center	Maywood	Illinois	United States	60153
15	LSU HC	Sheveport	Louisiana	United States	71130
16	Tufts England Medical Center	Boston	Massachusetts	United States	02111
17	Mass General Hospital	Boston	Massachusetts	United States	02114
18	Dana-Farber Cancer Center	Boston	Massachusetts	United States	02115
19	Univ. of Michigan Comp. Cancer Center,	Ann Arbor	Michigan	United States	48109-0922
20	VA Medical Center	Minneapolis	Minnesota	United States	55417
21	Mayo Clinic	Rochester	Minnesota	United States	55905
22	Washington University School of Medicine	St. Louis	Missouri	United States	63110
23	Hackensack University Medical Center, David Jurist Research Building	Hackensack	New Jersey	United States	07601
24	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
25	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
26	St. Vincent's Comprehensive Cancer Center	New York	New York	United States	10011
27	Weill Medical College of Cornell University, NY Presbyterian Hospital	New York	New York	United States	10021
28	Rochester General Hospital	Rochester	New York	United States	14621
29	University of Rochester Medical Center, James P. Wilmot Cancer Center	Rochester	New York	United States	14642
30	Charlotte Hematology Oncology Associates	Charlotte	North Carolina	United States	28203
31	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
32	University of Pennsylvania Cancer Center	Philadelphia,	Pennsylvania	United States	19104
33	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
34	Trident Palmetto Hematology/Oncology	Charleston	South Carolina	United States	29406
35	Division of Hematology/Stem Cell Transplant	Nashville	Tennessee	United States	37232-5505
36	Texas Oncology at Medical City Dallas Hospital	Dallas	Texas	United States	75225
37	MD Anderson Cancer Center	Houston	Texas	United States	77030
38	Fred Hutchinson Cancer Center	Seattle	Washington	United States	98109
39	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
40	Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie	Wien		Austria	1171
41	ACZA, Campus Stuivenberg	Antwerpen		Belgium	2060
42	AZ St. Jan, Dept of Haematology	Brugge		Belgium	8000
43	CHU Erasme / ULB University	Brussels		Belgium	1070
44	Institue Jules Bordet, Unite Sterile	Bruxelles		Belgium	1000
45	C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie	Charleroi		Belgium	6000
46	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
47	London Health Sciences Center	London	Ontario	Canada	N6A 4G5
48	Toronto General Research Institute	Toronto	Ontario	Canada	M5G2M9
49	McGill University Clinical Research Program	Montreal	Quebec	Canada	H2W 1S6
50	Hospital Claude Huriez	Lile	Cedex	France	59037
51	Hoptial Hotel Dieu	Paris	Cedex	France	75181
52	Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique	Toulouse	Cedex	France	31059
53	Hopital de Brabois	Vandoeuvre	Cedex	France	54511
54	Centre Hospitalier Lyon Sud	Cedex		France	69495
55	Hopital Antoine Beclere	Clamart		France	92140
56	Hospital Saint-Louis	Paris		France	75010
57	Universitatsklinikum Charite Medizinische Klinik und Poliklinik	Berlin		Germany	10098
58	Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet	Bonn		Germany	53127
59	University of Erlangen-Nurenberg, Division of Hematology/Oncology	Erlangen		Germany	91054
60	Medical University Clinic (Oncology/Haematology)	Hamburg		Germany	20246
61	Universitatsklinikum Heidelberg	Heidelberg		Germany	69115
62	Johannes-Gutenberg-University Medical School, Department of Medicine III	Mainz		Germany	55101
63	Uniklinikum Muenster, Medizinische Klinik und Poliklinik A	Muenster		Germany	48129
64	Belfast City Hospital, Haematology Department	Belfast		Ireland	BT9 7AB
65	Hadassah University Hospital	Jerusalem		Israel	91120
66	Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1	Roma		Italy	00161
67	Azienda Ospedaliera, S. Giovanni Battista	Torino		Italy	10126
68	Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology	Rotterdam		Netherlands	3075
69	Hospital Clinico Universitario de Barcelona, Hematologia	Barcelona		Spain	08036
70	University Hospital of Salamanca, Hematology Dept	Salamanca		Spain	37007
71	Huddinge University Hospital M54, Department of Haematology	Stockholm		Sweden	14186
72	Adult Leukaemia Unit, Christie Hospital	Withington	Manchester	United Kingdom	M20 4BX
73	Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
74	Leeds General Infirmary, Department of Haematology	Leeds		United Kingdom	LS1 3EX
75	Department of Haematology, ICSM	London		United Kingdom	W12 0NN
76	Royal Marsden Hospital	Sutton		United Kingdom	SM2 5PT