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

Primary Purpose

Relapsed and/or Refractory Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Elotuzumab
Thalidomide
Dexamethasone
Cyclophosphamide
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed and/or Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Key Inclusion Criteria:

  • Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy
  • Patient received 5 or fewer prior lines of therapy
  • Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients)

  • Measurable disease as defined by at least 1 of the following:

    • Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or
    • Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or
    • Involved serum free light chain level ≥10 mg/dL, provided the free light chain ratio is abnormal

Key Exclusion Criteria:

  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  • Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia
  • Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50%
  • Electrocardiogram finding of QTc ≥450 msec
  • Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L)
  • Diagnosis of nonsecretory myeloma
  • Active hepatitis A, B, or C virus infection
  • Grade ≥2 neuropathy

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Secondary Outcome Measures

Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.

Full Information

First Posted
June 28, 2012
Last Updated
March 17, 2017
Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT01632150
Brief Title
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and/or Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Elotuzumab
Other Intervention Name(s)
BMS-901608, HuLuc63
Intervention Description
Powder for solution, 400-mg vials, for infusion
Intervention Type
Biological
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid®
Intervention Description
50-mg capsules administered orally
Intervention Type
Biological
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
Intervention Type
Biological
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan, Endoxan, Neosar
Intervention Description
50-mg tablets administered orally
Primary Outcome Measure Information:
Title
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame
From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
Title
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame
From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
Secondary Outcome Measure Information:
Title
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Description
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.
Time Frame
From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
Title
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Description
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.
Time Frame
From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Key Inclusion Criteria: Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy Patient received 5 or fewer prior lines of therapy Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients) Measurable disease as defined by at least 1 of the following: Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or Involved serum free light chain level ≥10 mg/dL, provided the free light chain ratio is abnormal Key Exclusion Criteria: Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50% Electrocardiogram finding of QTc ≥450 msec Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2*10^9/L) Diagnosis of nonsecretory myeloma Active hepatitis A, B, or C virus infection Grade ≥2 neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
LaLaguna, S Cruz Tener
ZIP/Postal Code
38320
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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