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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT01615029
First received: June 6, 2012
Last updated: September 23, 2014
Last verified: September 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: March 2012
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

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Denmark
Rigshospitalet
Copenhagen, Denmark, DK-2100
Vejle Sygehus
Vejle, Denmark, DK-7100
France
Hopital Claude Huriez CHRU de Lille
Lille, France, 59037
CHU de Nantes/Service d'Hématolgie Clinique
Nantes, France, 44093
CHU de Nancy
Vandoeuvre Lès Nancy, France, 54511
Italy
Ospedali riuniti "Villa Sofia-Cervello"
Palermo, Italy, 90100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 100126
Netherlands
Universitair Medisch Centrum UMC
Utrecht, The Netherlands, Netherlands, 3584
United Kingdom
Sarah Cannon Reserach Institute
London, United Kingdom, W1G 6AD
St Bartholemew's Hospital, Old Anatomy Building, Charterhouse Square
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: September 23, 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
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
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2014