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: January 29, 2016
Last verified: December 2015
  Purpose
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.

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:
  • Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) [ Time Frame: Day 1 of treatment through 19 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Day 1 of treatment through 19 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 of treatment through 19 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 of treatment through 19 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 51
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide Biological: Elotuzumab
Powder for solution, 400-mg vials, for infusion
Other Names:
  • BMS-901608
  • HuLuc63
Biological: Thalidomide
50-mg capsules administered orally
Other Name: Thalomid®
Biological: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
Biological: Cyclophosphamide
50-mg tablets administered orally
Other Names:
  • Cytoxan
  • Endoxan
  • Neosar

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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, 08035
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08041
Local Institution
Barcelona, Spain, 08916
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:
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
Results First Received: December 22, 2015
Last Updated: January 29, 2016
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
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Cyclophosphamide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 28, 2016