|
A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 Clinical research trials and A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039. A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 clinical trial. Test subjects typically obtain the finest healthcare available for their A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039  A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): Millennium Pharmaceuticals ,
Synopsis: The purpose of this study is to allow patients to receive VELCADEâ„¢ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.
Details: 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 VELCADEâ„¢ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 600
Location and Contact Information:
LSU HC *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting
Weill Medical College of Cornell University, NY Presbyterian Hospital *Recruiting*
New York City, New York, 10021
United States
Recruiting
Fred Hutchinson Cancer Center *Recruiting*
Seattle, Washington, 98109
United States
Recruiting
Royal Marsden Hospital *Recruiting*
Sutton, , SM2 5PT
United Kingdom
Recruiting
Hematology/Oncology Associates, PA *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting
Long Island Jewish Medical Center *Recruiting*
New Hyde Park, New York, 11040
United States
Recruiting
Leeds General Infirmary, Department of Haematology *Recruiting*
Leeds, , LS1 3EX
United Kingdom
Recruiting
Kaiser Permanente Medical Center *Recruiting*
Vallejo, California, 94589
United States
Recruiting
Scripps Clinic, Green Cancer Center *Recruiting*
La Jolla, California, 92307
United States
Recruiting
Texas Oncology at Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75225
United States
Recruiting
Lombardi Cancer Center, Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting
Belfast City Hospital, Haematology Department *Recruiting*
Belfast, , BT9 7AB
Ireland
Recruiting
Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting
Rochester General Hospital *Recruiting*
Rochester, New York, 14621
United States
Recruiting
Universitatsklinikum Heidelberg *Recruiting*
Heidelberg, , 69115
Germany
Recruiting
Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie *Recruiting*
Wien, , 1171
Austria
Recruiting
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet *Recruiting*
Bonn, , 53127
Germany
Recruiting
Adult Leukaemia Unit, Christie Hospital *Recruiting*
Withington, Manchester, M20 4BX
United Kingdom
Recruiting
Johannes-Gutenberg-University Medical School, Department of Medicine III *Recruiting*
Mainz, , 55101
Germany
Recruiting
Loyola University Medical Center: Cardinal Bernardin Cancer Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting
Mass General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting
University of Arkansas Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting
Department of Haematology, ICSM *Recruiting*
London, , W12 0NN
United Kingdom
Recruiting
Toronto General Research Institute *Recruiting*
Toronto, Ontario, M5G2M9
Canada
Recruiting
University of Rochester Medical Center, James P. Wilmot Cancer Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting
Centre Hospitalier Lyon Sud *Recruiting*
Cedex, , 69495
France
Recruiting
University of Pennsylvania Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting
Hopital Antoine Beclere *Recruiting*
Clamart, , 92140
France
Recruiting
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting
Institue Jules Bordet, Unite Sterile *Recruiting*
BRUXELLES, , 1000
Belgium
Recruiting
Hoptial Hotel Dieu *Recruiting*
Paris, Cedex, 75181
France
Recruiting
ACZA, Campus Stuivenberg *Recruiting*
Antwerpen, , 2060
Belgium
Recruiting
Hospital Clinico Universitario de Barcelona, Hematologia *Recruiting*
Barcelona, , 08036
Spain
Recruiting
St. Vincent's Comprehensive Cancer Center *Recruiting*
New York City, New York, 10011
United States
Recruiting
H. Lee Moffitt Cancer Center *Recruiting*
Tampa, Florida, 33612
United States
Recruiting
Trident Palmetto Hematology/Oncology *Recruiting*
Charleston, South Carolina, 29406
United States
Recruiting
Queen Elizabeth Hospital *Recruiting*
Birmingham, , B15 2TH
United Kingdom
Recruiting
Huddinge University Hospital M54, Department of Haematology *Recruiting*
Stockholm, , 14186
Sweden
Recruiting
University Hospital of Salamanca, Hematology Dept *Recruiting*
Salamanca, , 37007
Spain
Recruiting
McGill University Clinical Research Program *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting
Northwestern University Medical School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting
VA Medical Center *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting
Hackensack University Medical Center, David Jurist Research Building *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting
London Health Sciences Center *Recruiting*
London, Ontario, N6A 4G5
Canada
Recruiting
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1 *Recruiting*
Roma, , 00161
Italy
Recruiting
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology *Recruiting*
Rotterdam, , 3075
Netherlands
Recruiting
Univ. of Michigan Comp. Cancer Center, *Recruiting*
Ann Arbor, Michigan, 48109-0922
United States
Recruiting
University of Erlangen-Nurenberg, Division of Hematology/Oncology *Recruiting*
Erlangen, , 91054
Germany
Recruiting
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie *Recruiting*
Charleroi, , 6000
Belgium
Recruiting
Hopital de Brabois *Recruiting*
Vandoeuvre, Cedex, 54511
France
Recruiting
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Tufts England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263
United States
Recruiting
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Hospital Claude Huriez *Recruiting*
Lile, Cedex, 59037
France
Recruiting
Medical College of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting
Charlotte Hematology Oncology Associates *Recruiting*
Charlotte, North Carolina, 28203
United States
Recruiting
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A *Recruiting*
Muenster, , 48129
Germany
Recruiting
Med Star Institute *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting
Azienda Ospedaliera, S. Giovanni Battista *Recruiting*
Torino, , 10126
Italy
Recruiting
Division of Hematology/Stem Cell Transplant *Recruiting*
Nashville, Tennessee, 37232-5505
United States
Recruiting
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique *Recruiting*
Toulouse, Cedex, 31059
France
Recruiting
Hospital Saint-Louis *Recruiting*
Paris, , 75010
France
Recruiting
Hadassah University Hospital *Recruiting*
Jerusalem, , 91120
Israel
Recruiting
University of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting
Universitatsklinikum Charite Medizinische Klinik und Poliklinik *Recruiting*
Berlin, , 10098
Germany
Recruiting
Dana-Farber Cancer Center *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting
City of Hope *Recruiting*
Duarte, California, 91010
United States
Recruiting
Medical University Clinic (Oncology/Haematology) *Recruiting*
Hamburg, , 20246
Germany
Recruiting
Loma Linda University Medical Center *Recruiting*
Loma Linda, California, 92354
United States
Recruiting
AZ St. Jan, Dept of Haematology *Recruiting*
Brugge, , 8000
Belgium
Recruiting
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting
CHU Erasme / ULB University *Recruiting*
Brussels, , 1070
Belgium
Recruiting
Additional Information:
Study ID Numbers: M34101-040;
Study Start Date: April 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063726
Other Multiple Myeloma Studies:
1. Study of SGN-40 (anti-huCD40 mAb) in Patients with Refractory or Recurrent Multiple Myeloma
2. The Role of Cyclosporin in Blood Cell Transplants with T-Cell Add-Back for Blood Cancers
3. Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation
4. Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
5. Safety and efficacy of single-agent CC-5013 in subjects with relapsed and refractory multiple myeloma
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
|
|
|
|
|
|
|
|
