ClinicalTrials.gov

History of Changes for Study: NCT00546780
A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse (TIME-1)
Latest version (submitted June 21, 2011) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 18, 2007 None (earliest Version on record)
2 October 24, 2007 Recruitment Status, Study Status and Contacts/Locations
3 January 21, 2008 Study Status, Arms and Interventions, Contacts/Locations, Study Design, Outcome Measures and Sponsor/Collaborators
4 March 4, 2008 Contacts/Locations and Study Status
5 March 14, 2008 Contacts/Locations and Study Status
6 April 14, 2008 Study Status and Contacts/Locations
7 May 2, 2008 Study Status and Contacts/Locations
8 May 25, 2008 Contacts/Locations and Study Status
9 May 30, 2008 Contacts/Locations and Study Status
10 June 16, 2008 Study Status, Contacts/Locations and Sponsor/Collaborators
11 June 24, 2008 Contacts/Locations and Study Status
12 July 30, 2008 Study Status and Contacts/Locations
13 September 4, 2008 Contacts/Locations, Study Identification, Sponsor/Collaborators, Study Status and Study Description
14 October 10, 2008 Contacts/Locations, Study Status and References
15 October 20, 2008 Contacts/Locations and Study Status
16 November 4, 2008 Contacts/Locations and Study Status
17 November 7, 2008 Arms and Interventions, Study Status, Eligibility and Study Identification
18 November 19, 2008 Contacts/Locations and Study Status
19 December 8, 2008 Contacts/Locations and Study Status
20 December 22, 2008 Contacts/Locations and Study Status
21 January 6, 2009 Contacts/Locations and Study Status
22 January 21, 2009 Contacts/Locations, Study Design and Study Status
23 February 9, 2009 Contacts/Locations and Study Status
24 February 25, 2009 Contacts/Locations and Study Status
25 March 6, 2009 Contacts/Locations and Study Status
26 March 24, 2009 Contacts/Locations and Study Status
27 March 26, 2009 Recruitment Status, Study Status and Contacts/Locations
28 April 9, 2009 Contacts/Locations and Study Status
29 April 22, 2009 Contacts/Locations and Study Status
30 May 6, 2009 Contacts/Locations and Study Status
31 May 20, 2009 Contacts/Locations and Study Status
32 June 4, 2009 Contacts/Locations and Study Status
33 June 17, 2009 Contacts/Locations and Study Status
34 July 8, 2009 Contacts/Locations and Study Status
35 July 16, 2009 Contacts/Locations and Study Status
36 August 5, 2009 Study Status, Contacts/Locations and Study Design
37 August 19, 2009 Contacts/Locations and Study Status
38 September 2, 2009 Contacts/Locations and Study Status
39 September 22, 2009 Contacts/Locations and Study Status
40 October 23, 2009 Contacts/Locations and Study Status
41 November 4, 2009 Contacts/Locations and Study Status
42 November 16, 2009 Study Status
43 December 16, 2009 Study Status
44 January 12, 2010 Study Status
45 February 3, 2010 Study Status
46 February 18, 2010 Contacts/Locations and Study Status
47 March 4, 2010 Contacts/Locations and Study Status
48 March 17, 2010 Contacts/Locations and Study Status
49 March 31, 2010 Study Status
50 April 13, 2010 Study Status and Contacts/Locations
51 April 27, 2010 Contacts/Locations and Study Status
52 May 21, 2010 Contacts/Locations and Study Status
53 June 14, 2010 Study Status
54 June 29, 2010 Study Status
55 July 15, 2010 Study Status
56 July 26, 2010 Study Status
57 August 11, 2010 Study Status
58 August 30, 2010 Study Status
59 September 13, 2010 Study Status
60 October 4, 2010 Study Status
61 October 12, 2010 Study Status
62 November 9, 2010 Study Status
63 December 2, 2010 Study Status
64 January 6, 2011 Contacts/Locations and Study Status
65 January 24, 2011 Study Status
66 February 10, 2011 Study Status
67 February 22, 2011 Study Status
68 March 8, 2011 Study Status
69 March 23, 2011 Study Status
70 May 10, 2011 Recruitment Status, Study Status and Study Design
71 June 21, 2011 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT00546780
Submitted Date:  October 18, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: KAG-301
Brief Title: A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse (TIME-1)
Official Title: Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2007
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: October 17, 2007
First Submitted that
Met QC Criteria:
October 18, 2007
First Posted: October 19, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 18, 2007
Last Update Posted: October 19, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a phase 3, open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953), the study agent developed by Kosan Biosciences, in combination with a fixed dose of bortezomib versus bortezomib alone.
Detailed Description: Phase 3 combination study comparing tanespimycin (KOS-953) plus bortezomib to bortezomib alone in patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow transplantation. Primary objective is to compare the progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in combination with bortezomib versus that associated with administration of bortezomib alone.
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Heat Shock Protein 90
Hsp90
KOS-953
17-AAG
bortezomib
first relapse
tanespimycin
TIME-1
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: tanespimycin and bortezomib
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Good performance status
  • Histologic evidence of multiple myeloma

Exclusion Criteria:

  • Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
  • Known infections of HAV, HBV, HCV, or HIV
  • Chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.
Open or close this module Contacts/Locations
Central Contact Person: Kosan Clinical Trials, Kosan Biosciences, Inc.
Telephone: 1-800-605-6726
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Multiple Myeloma Research Foundation
Description: The International Myeloma Foundation
Description: American Cancer Society
Description: The National Cancer Institute
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services