Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Genmab
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT01615029
First received: June 6, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Daratumumab
Drug: Lenalidomide
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 Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and 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 Len/Dex [ Time Frame: Last patient Last treatment of Part 2 - maximum 24 cycles (approximately 2 years) or until progression. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the efficacy of daratumumab when given in combination with Len/Dex [ Time Frame: Last patient Last treatment of Part 2 - maximum 24 cycles (approximately 2 years) or until progression. ] [ Designated as safety issue: No ]
  • Evaluate the PK profile of daratumumab when given in combination with Len/Dex [ Time Frame: Last patient Last treatment of Part 2 - maximum 24 cycles (approximately 2 years) or until progression. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daratumumab Drug: Daratumumab

Part I (dose escalation): 8 weekly infusions, followed by 8 bi-weekly infusions. The monthly infusions until progression

Part II: 8 weekly infusions, followed by 8 bi-weekly infusions. The monthly infusions until progression, dose is MTD as defined in Part I

Drug: Lenalidomide
Orally day 1-21 in cycles of 28 days.
Drug: Dexamethasone
Weekly administration

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 Len/Dex in 28 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 Len/Dex.
  • (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 Len/Dex.
  • 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 lenalidomide, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with lenalidomide).
  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: NCT01615029

Contacts
Contact: Franca Maria Riganti, Senior Project Manager franca-maria.riganti@incresearch.com
Contact: Ans Kramer, Project Manager Ans.Kramer@INCResearch.com

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02115
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Peter Gimsing         
Principal Investigator: Peter Gimsing         
Vejle Sygehus Recruiting
Vejle, Denmark, DK-7100
Contact: Torben Plesner, MD         
Principal Investigator: Torben Plesner, MD         
France
Hopital Claude Huriez CHRU de Lille Recruiting
Lille, France, 59037
Contact: Thierry Facon, MD    +33.3.20.44.57.12    thierry.facon@chru-lille.fr   
Principal Investigator: Thierry Facon, MD         
CHU de Nantes/Service d'Hématolgie Clinique Recruiting
Nantes, France, 44093
Contact: Philippe Moreau, MD    +33.2.40.08.32.71    philippe.moreau@chu-nantes.fr   
Principal Investigator: Philippe Moreau, MD         
CHU de Nancy Active, not recruiting
Vandoeuvre Lès Nancy, France, 54511
Italy
Ospedali riuniti "Villa Sofia-Cervello" Active, not recruiting
Palermo, Italy, 90100
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 100126
Contact: Mario Boccadoro, MD    0039 011 6334263    mario.boccadoro@unito.it   
Principal Investigator: Mario Boccadoro, MD         
Netherlands
Universitair Medisch Centrum UMC Active, not recruiting
Utrecht, The Netherlands, Netherlands, 3584
United Kingdom
Sarah Cannon Reserach Institute Recruiting
London, United Kingdom, W1G 6AD
Contact: Tobias Arkenau         
Principal Investigator: Tobias Arkenau         
St Bartholemew's Hospital, Old Anatomy Building, Charterhouse Square Active, not recruiting
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Genmab
Investigators
Principal Investigator: Torben Plesner, MD Vejle Hospital
Principal Investigator: Paul Richardson, MD Dana Farber
  More Information

No publications provided

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT01615029     History of Changes
Other Study ID Numbers: GEN503
Study First Received: June 6, 2012
Last Updated: February 27, 2014
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
Lenalidomide
Thalidomide
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

ClinicalTrials.gov processed this record on July 20, 2014