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Sponsored by: |
Genmab |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00574288 |
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.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: HuMax-CD38 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | HuMax-CD38 Safety Study in Multiple Myeloma - Open Label, Dose-Escalation Followed by Open Label, Randomised, Parallel Group |
Estimated Enrollment: | 122 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part 2 low: Experimental |
Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
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Part 2 middle: Experimental |
Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
|
Part 2 high: Experimental |
Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
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This study is conducted in two parts. In part I, subjects are enrolled into cohorts at increasing dose levels. Subject safety and efficacy during part I will determine the doses used for Part II. Part II will monitor three parallel treatment arms(Low, Middle, and High)
Both Part I and Part II are open-label/unmasked.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with multiple myeloma who are:
Contact: Jette Laub, Lead CRA | +45 3272 8844 | jel@genmab.com |
Contact: Cathy Dawson, Int Proj Mgr | 01 609 524 0842 | c.dawson@genamab.com |
Denmark | |
Vejle Hospital | Recruiting |
Vejle, Denmark, 7100 | |
Principal Investigator: Torbin Plesner, MD | |
Rigshospitalet Clinic of Hematology L4042 | Not yet recruiting |
Copenhagen, Denmark | |
Principal Investigator: Peter Gimsing, MD | |
Sub-Investigator: Ulrich Lessen, MD | |
Sweden | |
Karolinska University Hospital - Huddinge | Recruiting |
Stockholm, Sweden | |
Contact: Hareth Nahi, MD | |
Principal Investigator: Hareth Nahi, MD | |
Sahlgrenska university Hospital | Recruiting |
Goteburg, Sweden | |
Principal Investigator: Ulf-Henrik Melquist, MD |
Principal Investigator: | Paul Richardson | Dana-Farber |
Responsible Party: | Genmab A/S ( Jette Laub, Lead CRA ) |
Study ID Numbers: | GEN501 |
Study First Received: | December 14, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00574288 |
Health Authority: | Denmark: Danish Medicines Agency; Sweden: Medical Products Agency |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |