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Daratumumab(HuMax®-CD38)Safety Study in Multiple Myeloma
This study is currently recruiting participants.
Verified October 2011 by Genmab

First Received on December 14, 2007.   Last Updated on October 25, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. PFS OS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

Detailed Description:

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
Criteria

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

  1. Plasma cell leukemia .
  2. Known amyloidosis
  3. 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.

  4. Sensory or motor neuropathy ≥ grade 3.
  5. Past or current malignancy,
  6. Chronic or ongoing active infectious disease
  7. Clinically significant cardiac disease
  8. Significant concurrent, uncontrolled medical condition including, but not limited to, renal (except related to MM), hepatic, hematological except MM, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
  9. Patients with baseline QTcF > 470 ms, as well as those with complete left bundle branch block (defined as a QRS ≥ 120 ms in left bundle branch block form).
  10. Hypokalemia
  11. Clinical signs of meningeal involvement of MM.
  12. Known severe chronic obstructive pulmonary disease or asthma defined as FEV1< 60% of expected.
  13. History of significant cerebrovascular disease.
  14. Known Human Immunodeficiency Virus seropositivity.
  15. Positive serology for hepatitis B
  16. Screening laboratory values
  17. Concomitant corticosteroid
  18. Other chemotherapy that is or may be active against myeloma within 3 weeks prior to Visit 2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574288

Contacts
Contact: Stephanie Nardella, Project Manager +33 1 46902560 snardella@incresearch.com
Contact: Sigrid Gruijs, Project Director +31 20 3018 520 sgruijs@incresearch.com

Locations
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            
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Paul Richardson Dana-Farber
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 09, 2012