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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01632150
First received: June 28, 2012
Last updated: August 7, 2014
Last verified: August 2014
  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:


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: May 2012
Estimated Study Completion Date: June 2015
Primary Completion Date: October 2013 (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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Confirmed diagnosis of previously treated multiple myeloma with documented progression International Myeloma Working Group (IMWG) criteria after or during the most recent therapy
  • Patient received 5 or less prior lines of 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 immunoglobulin G (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
  • LVEF by echocardiogram or Multi Gated Acquisition (MUGA) must not be ≤50%
  • Electrocardiogram (ECG) QTc ≥450 msec will be excluded
  • 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
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: NCT01632150

Locations
Spain
Local Institution
Barcelona, Spain, 08916
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08041
Local Institution
Barcelona, Spain, 08035
Local Institution
LaLaguna, S Cruz Tener, Spain, 38320
Local Institution
Madrid, Spain, 28034
Local Institution
Madrid, Spain, 28041
Local Institution
Salamanca, Spain, 37007
Local Institution
Sevilla, Spain, 41013
Local Institution
Zaragoza, Spain, 50009
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: August 7, 2014
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 October 19, 2014