NCT01632150 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-04-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)

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outcome · POSTED

Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event

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outcome · POSTED

Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: Elotuzumab
Biological: Thalidomide
Biological: Dexamethasone
Biological: Cyclophosphamide
label
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
type
EXPERIMENTAL

interventions

arm Group Labels
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
description
Powder for solution, 400-mg vials, for infusion
name
Elotuzumab
other Names
BMS-901608
HuLuc63
type
BIOLOGICAL
arm Group Labels
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
description
50-mg capsules administered orally
name
Thalidomide
other Names
Thalomid®
type
BIOLOGICAL
arm Group Labels
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
description
2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
name
Dexamethasone
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
BIOLOGICAL
arm Group Labels
Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
description
50-mg tablets administered orally
name
Cyclophosphamide
other Names
Cytoxan
Endoxan
Neosar
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 51
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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
description
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.
measure
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

secondary Outcomes

description
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.
measure
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
description
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.
measure
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

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice