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| Sponsor: | Genmab |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Daratumumab(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: | June 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| 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
|
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 |
Inclusion criteria
1. Diagnosis of MM requiring systemic therapy (34): 2. Age ≥ 18 years. 3. ECOG performance status (0-2). 4. Life expectancy > 3 months. 5. Relapsed or refractory to two or more different prior therapies, Exclusion criteria
Patients who previously have received an allogeneic stem cell transplant and receive or have received immunosuppressive therapy within the last three months.
or
Patients who previously have received an allogeneic stem cell transplant and have signs of acute or chronic graft-versus-host disease.
Contacts and Locations| Contact: Stephanie Nardella, Project Manager | +33 1 46902560 | snardella@incresearch.com |
| Contact: Sigrid Gruijs, Project Director | +31 20 3018 520 | sgruijs@incresearch.com |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: Jacob Laubach, M.D | |
| Denmark | |
| Rigshospitalet Clinic of Hematology L4042 | Recruiting |
| Copenhagen, Denmark | |
| Principal Investigator: Peter Gimsing, MD | |
| Sub-Investigator: Ulrich Lessen, MD | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark, 7100 | |
| Principal Investigator: Torben Plesner, MD | |
| Netherlands | |
| Uni.Med Center Utrecht | Recruiting |
| Utrecht, Netherlands | |
| Principal Investigator: H M Lockhurst, MD, PhD | |
| Sweden | |
| Sahlgrenska university Hospital | Recruiting |
| Goteburg, Sweden | |
| Principal Investigator: Ulf-Henrik Melquist, MD | |
| Karolinska University Hospital - Huddinge | Recruiting |
| Stockholm, Sweden | |
| Contact: Hareth Nahi, MD | |
| Principal Investigator: Hareth Nahi, MD | |
| Principal Investigator: | Paul Richardson | Dana-Farber |
More Information
| Responsible Party: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00574288 History of Changes |
| Other Study ID Numbers: | GEN501 |
| Study First Received: | December 14, 2007 |
| Last Updated: | October 25, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |