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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01632150
• Date of registration: 28/06/2012
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
• Scientific title: Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
• Date of first enrolment: May 2012
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01632150
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany, Spain

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsed and/or Refractory Multiple Myeloma

Intervention(s)

Biological: Cyclophosphamide

Biological: Elotuzumab

Biological: Thalidomide

Biological: Dexamethasone

Primary Outcome(s)

Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) [Time Frame: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated]

Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) [Time Frame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment]

Secondary Outcome(s)

Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event [Time Frame: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment]

Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event [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 ID(s)

2011-005121-49

CA204-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie

Results

• Results available: Yes
• Date Posted: 26/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01632150