Daratumumab in Combination With Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma

This study has been withdrawn prior to enrollment.
(Other trial designs for combination options with daratumumab and existing treatments are being explored and further details will be released later)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT01620879
First received: June 6, 2012
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory Multiple Myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: Daratumumab
Drug: bortezomib
Drug: dexamethasone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: Yes ]
    Frequency and intensity of adverse events and laboratory measurements


Secondary Outcome Measures:
  • Evaluate the efficacy of daratumumab when given in combination with bortezomib and dexamethasone [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: No ]
    Response evaluation in accordance to International Myeloma Workshop Consensus Panel 1 (Rajkumar et al, Blood 2011)

  • PK profile of daratumumab [ Time Frame: Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment. ] [ Designated as safety issue: No ]
    PK characteristics of daratumumab when given in combination with bortezomib and dexamethasone. Individual patient PK profiles and PK-parameters will be estimated.


Enrollment: 0
Study Start Date: June 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: daratumumab Drug: Daratumumab

Part I (dose escalation): Daratumumab will be administered in 21-day cycles. For the first 2 cycles (6 weeks), administration of daratumumab will be weekly . In Cycles 3 through 8 (18 weeks), daratumumab will be administered on Days 1 and 11 of each 21-day cycle.

Part 2: same as part I with dose as defined in Part I

Drug: bortezomib
IV administration day 1, 4, 8 and 11 in 21 day cycles.
Drug: dexamethasone
in combination with the daratumumab/bortezomib treatment.

Detailed Description:

The study is conducted in two parts. The dose escalation portion of the trial (Part 1) subjects are enrolled into cohorts at increasing dose levels of daratumumab in combination with bortezomib and dexemethasone in 21 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (Part 1) Have MM after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with bortezomib and dexamethasone.
  • (Part 2) Have relapsed MM after receiving a minimum of 1 and a maximum of 3 prior lines of therapy and be eligible for treatment with bortezomib and dexamethasone.
  • Be older than or be 18 years of age.
  • ECOG performance status (0-2).
  • Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

  • Have previously received an allogenic stem cell transplant.
  • Have received autologous stem cell transplant within 12 weeks before the first infusion.
  • Have received chemotherapy or any experimental drug or therapy within 3 weeks before the first infusion.
  • Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the first infusion.
  • Have multiple myeloma that is refractory to bortezomib, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with bortezomib.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620879

Locations
Denmark
Vejle sygehus
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Antonio Palumbo, MD Department of Hematology, University of Torino
Principal Investigator: Paul Richardson, MD Dana Farber
  More Information

No publications provided

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT01620879     History of Changes
Other Study ID Numbers: GEN504
Study First Received: June 6, 2012
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency

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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 22, 2014