Text Size

Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

This study is currently recruiting participants.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01632150
First received: June 28, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine how safe and well tolerated Elotuzumab is in combination with Thalidomide and Dexamethasone when treating patients with relapsed and/or refractory Multiple Myeloma (MM).


Condition Intervention Phase
Relapsed and/or Refractory Multiple Myeloma
 Biological: Elotuzumab
Biological: Thalidomide
Biological: Dexamethasone
Biological: Cyclophosphamide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects who experience one or more severe (Grade 3 or higher) non-hematologic adverse events [ Time Frame: Up to 60 days after the last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects who experience one or more dose reductions or discontinuation of study treatment due to drug related adverse events [ Time Frame: Up to 60 days after the last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elotuzumab +Thalidomide + Dexamethasone + Cyclophosphamide Biological: Elotuzumab
Solution, Intravenous (IV), 10 mg/kg, Cycle 1 & 2 - weekly. Every 2 weeks thereafter, Until progression/ treatment discontinuation
Other Names:
  • BMS-901608
  • HuLuc63
Biological: Thalidomide
Capsules, By mouth (PO), 50 mg, Cycle 1 - Daily days 1-14, Until progression/ treatment discontinuation
Other Name: Thalomid®
Biological: Thalidomide
Capsules, PO, 100 mg, Cycle 1 - Daily days 15-28, Until progression/ treatment discontinuation
Other Name: Thalomid®
Biological: Thalidomide
Capsules, PO, 200 mg, Cycle 2 onwards - Daily, Until progression/ treatment discontinuation
Other Name: Thalomid®
Biological: Dexamethasone
Tablets, PO, 28 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 &15 (cycles 3 and beyond), Until progression/ treatment discontinuation
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Biological: Dexamethasone
Tablets, PO, 40 mg , Once daily, on Days 8 & 22 (cycles 3 and beyond), Until progression/ treatment discontinuation
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Biological: Dexamethasone
Solution, IV, 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 &15 (cycles 3 and beyond), Until progression/ treatment discontinuation
Other Name: Decadron®
Biological: Cyclophosphamide
Tablets, PO, 50, Daily starting C3 (if applicable, for subjects not achieving Partial Response (PR) by end of Cycle 4), Until progression/ treatment discontinuation
Other Names:
  • Cytoxan
  • Endoxan
  • Neosar

  Eligibility

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

Inclusion Criteria:

  • Confirmed diagnosis of previously treated multiple myeloma with documented progression by International Myeloma Working Group (IMWG) criteria after/during most recent therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (safety lead-in cohort) or 0-2 (additional subjects)

  • Measurable disease as defined by at least one of the following;

    1. Serum IgG, IgA, IgM M-protein ≥ 0.5 g/dL, or serum IgD M-protein ≥ 0.05 g/dL; OR
    2. Urine M protein ≥ 200 mg excreted in a 24-hour collection sample; OR
    3. Involved serum free light chain level ≥ 10 mg/dL provided the free light chain ratio is abnormal

Exclusion Criteria:

  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  • Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma or Waldenström's macroglobulinemia
  • Active plasma cell leukemia (defined as either 20% of peripheral White Blood Cells (WBC) comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L to 2 x 100,000,0000/L)
  • Subjects with non-secretory myeloma
  • Active hepatitis A, B, or C
  • Grade ≥2 neuropathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632150

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Germany
Local Institution Not yet recruiting
Berlin, Germany, 13125
Contact: Site 2001            
Local Institution Not yet recruiting
Freiburg, Germany, 79106
Contact: Site 2003            
Local Institution Not yet recruiting
Heidelberg, Germany, 64120
Contact: Site 2000            
Local Institution Not yet recruiting
Munster, Germany, 48149
Contact: Site 2004            
Local Institution Not yet recruiting
Tubingen, Germany, 72076
Contact: Site 2002            
Spain
Local Institution Recruiting
Barcelona, Spain, 08041
Contact: Site 1001            
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 1010            
Local Institution Recruiting
Barcelona, Spain, 08916
Contact: Site 1004            
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 1006            
Local Institution Recruiting
Lalaguna-S. Cruz Tener, Spain, 38320
Contact: Site 1002            
Local Institution Recruiting
Madrid, Spain, 28047
Contact: Site 1005            
Local Institution Not yet recruiting
Madrid, Spain, 28034
Contact: Site 1007            
Local Institution Recruiting
Salamanca, Spain, 37007
Contact: Site 1000            
Local Institution Not yet recruiting
Sevilla, Spain, 41013
Contact: Site 1003            
Local Institution Recruiting
Zaragoza, Spain, 50009
Contact: Site 1008            
Local Institution Not yet recruiting
Zaragoza, Spain, 50009
Contact: Site 1009            
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01632150     History of Changes
Other Study ID Numbers: CA204-010, 2011-005121-49
Study First Received: June 28, 2012
Last Updated: January 22, 2013
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices

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
Cyclophosphamide
 Thalidomide
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013