Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Biological: Elotuzumab; Drug: Bortezomib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478048

2011-002695-16 (EudraCT Number)

CA204-009

Details and patient eligibility

About

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

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

Arm A: Elotuzumab + Bortezomib + Dexamethasone

Experimental group

Description:

On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered

Treatment:

Drug: Bortezomib

Biological: Elotuzumab

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Dexamethasone

Arm B: Bortezomib + Dexamethasone

Active Comparator group

Treatment:

Drug: Bortezomib

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Dexamethasone