Daratumumab(HuMax®-CD38)Safety Study in Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00574288
First received: December 14, 2007
Last updated: July 9, 2014
Last verified: July 2014
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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, Single-arm Study

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 until end of trial (Part 1 across 28 weeks; Part 2 across 27 weeks) [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events. Objective response according to International uniform response criteria for MM. Relative reduction in M-component. Time to progression. Duration of response. Progression Free Survival. Overall Survival. [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: December 2007
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 2 MTD as defined in Part 1 Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration
Other Name: daratumumab

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. In Part II subjects will be enrolled into one treatment arm; Maximal Tolerated Dose as defined in part I.

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
  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
  6. Signed Informed consent

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. A baseline QT interval as corrected by Fridericia's formula > 470 msec for female patients or > 450 msec for male patients or a complete left bundle branch block (defined as a QRS interval≥ 120 msec 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 1 (Part 2)
  19. Known hypersensitivity to components of the investigational product or severe allergic or anaphylactic reactions to humanized products
  20. Patients who have received treatment with any nonmarket drug substance within 4 weeks before Screening (Part 1: Visit 1; Part 2: Visit 0)
  21. Current participation in any other interventional clinical trial
  22. Patients known or suspected of not being able to comply with a trial protocol (eg, due to alcoholism, drug dependency, or psychological disorder)
  23. Breastfeeding women or women with a positive pregnancy test at Screening
  24. Women of childbearing potential not willing to use adequate contraception, defined as hormonal birth control or intrauterine device, during the trial and for 1 year after the last dose of daratumumab. For patients in the US, the use of a double-barrier method is also considered adequate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574288

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Denmark
Rigshospitalet Clinic of Hematology L4042
Copenhagen, Denmark
Vejle Hospital
Vejle, Denmark
Netherlands
VU University Medical Center
Amsterdam, Netherlands
Uni.Med Center Utrecht
Utrecht, Netherlands
Sweden
Skåne University Hospital
Lund, Sweden
Karolinska University Hospital - Huddinge
Stockholm, Sweden
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: July 9, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014