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

December 14, 2007
July 9, 2014
December 2007
January 2016   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00574288 on ClinicalTrials.gov Archive Site
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 ]
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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Daratumumab(HuMax®-CD38)Safety Study in Multiple Myeloma
Daratumumab(HuMax®-CD38)Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: HuMax-CD38
Concentrate for solution for infusion, intravenous administration
Other Name: daratumumab
Experimental: Part 2 MTD as defined in Part 1
Intervention: Drug: HuMax-CD38
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
112
May 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   Netherlands,   Sweden
 
NCT00574288
GEN501
Yes
Genmab
Genmab
Not Provided
Principal Investigator: Paul Richardson Dana-Farber
Genmab
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP