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Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed 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:
NCT01478048
First received: November 2, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will increase the time before myeloma worsens [progression free survival (PFS)].


Condition Intervention Phase
Multiple Myeloma
Biological: Elotuzumab
Drug: Bortezomib
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause [ Time Frame: Every 21 +/-7 days (Cycles 1-8) relative to the first dose of study medication ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause [ Time Frame: Every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS hazard ration in the subgroup of subjects with at least one FcγRIIIa V allele [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.

  • Difference in response rates between treatment arms in the overall population [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.

  • Estimate the difference in response rates between arms in the subgroup of subjects with at least one FcγRIIIa V allele [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Elotuzumab + Bortezomib + Dexamethasone
On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered
Biological: Elotuzumab
Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of study drug
Other Name: BMS-901608
Drug: Bortezomib
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
Other Name: Velcade®
Drug: Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
Drug: Dexamethasone
Tablets; Oral; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
Drug: Dexamethasone
Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
Active Comparator: Arm B: Bortezomib + Dexamethasone Drug: Bortezomib
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
Other Name: Velcade®
Drug: Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®

  Eligibility

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

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

  • Documented progression from most recent line of therapy
  • Measurable disease
  • 1 to 3 prior lines of therapy

    • Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:

      1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
      2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
      3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)

Exclusion Criteria:

  • Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
  • Active plasma cell leukemia
  • Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
  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: NCT01478048

  Show 76 Study Locations
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: NCT01478048     History of Changes
Other Study ID Numbers: CA204-009, 2011-002695-16
Study First Received: November 2, 2011
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:
Relapsed/Refractory Multiple Myeloma

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
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 20, 2014