Multiple MyelomaPhase 3NCT00063726
A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
A Phase 3 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 76 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib
- How many people
- 600 participants
- Where
- 76 sitesin 13 countries
- Study dates
- Apr 2002to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.):
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- 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.
Who cannot join
- 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.
Trial locations and contacts
76 sites in 13 countries.
76 sites in 13 countries
United States39 sites
Univ. of Michigan Comp. Cancer Center,
Ann Arbor, Michigan, 48109-0922
Emory University
Atlanta, Georgia, 30322
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Tufts England Medical Center
Boston, Massachusetts, 02111
Mass General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Trident Palmetto Hematology/Oncology
Charleston, South Carolina, 29406
Charlotte Hematology Oncology Associates
Charlotte, North Carolina, 28203
Northwestern University Medical School
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Texas Oncology at Medical City Dallas Hospital
Dallas, Texas, 75225
City of Hope
Duarte, California, 91010
Hackensack University Medical Center, David Jurist Research Building
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
Hematology/Oncology Associates, PA
Jacksonville, Florida, 32207
Scripps Clinic, Green Cancer Center
La Jolla, California, 92307
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Medical Center
Loma Linda, California, 92354
Loyola University Medical Center: Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
VA Medical Center
Minneapolis, Minnesota, 55417
Division of Hematology/Stem Cell Transplant
Nashville, Tennessee, 37232-5505
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
Weill Medical College of Cornell University, NY Presbyterian Hospital
New York, New York, 10021
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, 14642
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
LSU HC
Sheveport, Louisiana, 71130
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Kaiser Permanente Medical Center
Vallejo, California, 94589
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Med Star Institute
Washington D.C., District of Columbia, 20010
France7 sites
Centre Hospitalier Lyon Sud
Cedex, 69495
Hopital Antoine Beclere
Clamart, 92140
Hospital Claude Huriez
Lille, Cedex, 59037
Hoptial Hotel Dieu
Paris, Cedex, 75181
Hospital Saint-Louis
Paris, 75010
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
Toulouse, Cedex, 31059
Hopital de Brabois
Vandœuvre-lès-Nancy, Cedex, 54511
Germany7 sites
Universitatsklinikum Charite Medizinische Klinik und Poliklinik
Berlin, 10098
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
Bonn, 53127
University of Erlangen-Nurenberg, Division of Hematology/Oncology
Erlangen, 91054
Medical University Clinic (Oncology/Haematology)
Hamburg, 20246
Universitatsklinikum Heidelberg
Heidelberg, 69115
Johannes-Gutenberg-University Medical School, Department of Medicine III
Mainz, 55101
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
Münster, 48129
Belgium5 sites
ACZA, Campus Stuivenberg
Antwerp, 2060
AZ St. Jan, Dept of Haematology
Bruges, 8000
Institue Jules Bordet, Unite Sterile
Brussels, 1000
CHU Erasme / ULB University
Brussels, 1070
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
Charleroi, 6000
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Leeds General Infirmary, Department of Haematology
Leeds, LS1 3EX
Department of Haematology, ICSM
London, W12 0NN
Royal Marsden Hospital
Sutton, SM2 5PT
Adult Leukaemia Unit, Christie Hospital
Withington, Manchester, M20 4BX
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Health Sciences Center
London, Ontario, N6A 4G5
McGill University Clinical Research Program
Montreal, Quebec, H2W 1S6
Toronto General Research Institute
Toronto, Ontario, M5G2M9
Italy2 sites
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
Roma, 00161
Azienda Ospedaliera, S. Giovanni Battista
Torino, 10126
Spain2 sites
Hospital Clinico Universitario de Barcelona, Hematologia
Barcelona, 08036
University Hospital of Salamanca, Hematology Dept
Salamanca, 37007
Austria1 site
Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
Vienna, 1171
Netherlands1 site
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
Rotterdam, 3075
Sweden1 site
Huddinge University Hospital M54, Department of Haematology
Stockholm, 14186
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2003 (estimated)
- Study startApr 2002
- Primary completionMay 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063726
- Sponsor's protocol ID
- M34101-040
- Status last verified
- Jan 2012
- First submitted
- 2 Jul 2003
- Last updated
- 13 Jan 2012
- Results posted
- No
Publications
van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.
PubMed 21791470
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00063726
- Acronym / sponsor ID
- M34101-040
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- May 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 11 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Derived from this study: PubMed 21791470van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
76 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 76 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, France, Germany, Belgium, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00063726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.