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| Sponsor: | Genmab |
|---|---|
| Information provided by: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00574288 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| Part 2 low: Experimental |
Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration, weekly dosing for up to 8 weeks
|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients with multiple myeloma who are:
Contacts and Locations| Contact: Majken Westergaard, ICTM | +45 70202728 | m.westergaard@genmab.com |
| Contact: Henrik Skaksen, Lead CRA | +45 70202728 | h.skaksen@genmab.com |
| Denmark | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark, 7100 | |
| Principal Investigator: Torbin Plesner, MD | |
| Rigshospitalet Clinic of Hematology L4042 | 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 |
More Information
| Responsible Party: | Genmab A/S ( Ulla Thelin, Director ) |
| Study ID Numbers: | GEN501 |
| Study First Received: | December 14, 2007 |
| Last Updated: | December 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00574288 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency; Sweden: Medical Products Agency |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |
