ClinicalTrials.gov
History of Changes for Study: NCT00574288
HuMax-CD38 Safety Study in Multiple Myeloma
Latest version (submitted March 30, 2018) 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 December 14, 2007 None (earliest Version on record)
2 January 21, 2008 Study Status and Eligibility
3 April 11, 2008 Study Status
4 September 24, 2008 Contacts/Locations, Study Status and Sponsor/Collaborators
5 September 30, 2008 Contacts/Locations, Eligibility, Study Description and Study Status
6 January 19, 2009 Contacts/Locations, Study Status and Sponsor/Collaborators
7 July 6, 2009 Contacts/Locations, Study Status and Sponsor/Collaborators
8 December 11, 2009 Contacts/Locations, Study Status and Study Identification
9 June 18, 2010 Contacts/Locations and Study Status
10 November 18, 2010 Study Status
11 June 23, 2011 Contacts/Locations, Study Status, Outcome Measures and Sponsor/Collaborators
12 October 18, 2011 Contacts/Locations, Sponsor/Collaborators, Study Status and Eligibility
13 October 25, 2011 Study Identification and Study Status
14 May 2, 2012 Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design, Study Description, Oversight and Study Identification
15 March 4, 2013 Contacts/Locations, Study Status, Outcome Measures, Arms and Interventions, Eligibility and Study Description
16 August 9, 2013 Study Status and Contacts/Locations
17 November 5, 2013 Study Status and Contacts/Locations
18 January 20, 2014 Contacts/Locations and Study Status
19 April 7, 2014 Contacts/Locations, Study Status and Study Design
20 July 9, 2014 Recruitment Status, Contacts/Locations and Study Status
21 July 15, 2015 Arms and Interventions, Contacts/Locations, Outcome Measures, Study Identification, Study Status, Study Design, Study Description, Sponsor/Collaborators, Eligibility and Conditions
22 September 28, 2015 Study Status
23 December 21, 2015 Study Status
24 March 11, 2016 Study Status
25 August 25, 2016 Study Status and Study Identification
26 January 18, 2017 Study Status, Outcome Measures, Results and Study Design
27 June 13, 2017 Recruitment Status, Study Status, Baseline Characteristics, Study Design and Oversight
28 March 30, 2018 Outcome Measures, Adverse Events, Baseline Characteristics, Participant Flow, Study Status and Oversight
Comparison Format:
Scroll up to access the controls
Study NCT00574288
Submitted Date:  December 14, 2007 (v1)
Open or close this module Study Identification
Unique Protocol ID: GEN501
Brief Title: HuMax-CD38 Safety Study in Multiple Myeloma
Official Title: HuMax-CD38 Safety Study in Multiple Myeloma - Open Label, Dose-Escalation Followed by Open Label, Randomised, Parallel Group
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2007
Overall Status: Recruiting
Study Start: December 2007
Primary Completion:
Study Completion: December 2009 [Anticipated]
First Submitted: December 14, 2007
First Submitted that
Met QC Criteria:		 December 14, 2007
First Posted: December 17, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:		 December 14, 2007
Last Update Posted: December 17, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genmab
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: Establishment of safety profile of HuMax-CD38 when given as monotherapy in patients with multiple myeloma relapsed or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 122 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 2 low Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
Experimental: Part 2 middle Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
Experimental: Part 2 high Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Adverse events measured throughout the study from first treatment visit (visit 2) until end of trial (potentially 2 y after first treatment).
[ Time Frame: 2 years ]
Secondary Outcome Measures:
1. PK parameters based on serum/plasma conc. of HuMax-CD38. Objective response according to International uniform response criteria for MM. Relative reduction in M-component. Time to progression. Duration of response.
[ Time Frame: 2 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patient with multiple myeloma who are relapsed or refractory to at least two different prior therapies and without further established treatment options:
  2. Equal or older than 18 years of age.
  3. Life expectancy more than 3 months

Exclusion Criteria:

  1. Plasma cell leukemia defined as a plasma cell count more than 2000/mm3.
  2. Known amyloidosis
  3. Previous allogeneic transplant.
  4. Sensory or motor neuropathy equal or more than grade 3.
  5. Absolute neutrophil counts less than 1000/mm3
  6. Platelet count less than 100 x 10E9/L.
  7. Serum creatinine more than 2 x upper limit of normal value
  8. Significant concurrent, uncontrolled medical condition or infectious disease requiring treatment
  9. Past or current malignancy
Open or close this module Contacts/Locations
Central Contact Person: Anne Raben, Int. Clinical Trial Manager
Telephone: +45 22779677
Email: anr@genmab.com
Central Contact Backup: Jan H Petersen, Int. Clinical Project Leader
Telephone: +45 3377 9526
Email: jhp@genmab.com
Study Officials: Poul G Richardson, Clinical Director
Principal Investigator
Dana-Farber Cancer Institute, 44 Binney Street, LG-LC, Boston, MA 02115, USA
Locations: Denmark
Vejle Hospital, Department of Hematology, Section of Internal medicine
[Recruiting]
Vejle, Denmark, 7100
Contact:Contact: Torben Plesner, MD, PhD +45 79406313 torben.plesner@vgs.regionsyddanmark.dk
Contact:Contact: Lena B Hårbo, Study Nurse +45 79406316 lena.bjerre.haarbo@vgs.regionsyddanmark.dk
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
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