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

Phase 2

Completed

• Conditions: Relapsed and/or Refractory Multiple Myeloma
• Interventions: Biological: Elotuzumab; Biological: Thalidomide; Biological: Dexamethasone; Biological: Cyclophosphamide

• Registration Number: NCT01632150
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-02
• Primary Completion: 2013-10
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-12-02
• Disposition First Posted: 2015-12-03
• Results First Submitted: 2015-12-22
• Results First Submitted QC: 2016-01-29
• Results First Posted: 2016-02-26
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide	Thalidomide	-
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide	Cyclophosphamide	-
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide	Dexamethasone	-
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide	Elotuzumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)	From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated	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 Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)	From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment	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

Name	Time	Method
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event	From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment	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	From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated	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.

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Zaragoza, Spain