Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
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
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)
Time Frame: 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 Outcomes
- 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)
- 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)