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Trial record 68 of 372 for:    LENALIDOMIDE AND Dexamethasone

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

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ClinicalTrials.gov Identifier: NCT01891643
Recruitment Status : Active, not recruiting
First Posted : July 3, 2013
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

Condition or disease Intervention/treatment Phase
Newly Diagnosed, Previously Untreated Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Actual Study Start Date : September 30, 2013
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Experimental: Arm 1: Lenalidomide + Dexamethasone

Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug

Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide
Other Name: Revlimid®

Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®

Experimental: Arm 2: Lenalidomide + Dexamethasone + Elotuzumab

Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)

Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)]

Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)]

Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)]

Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)]

Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond)

Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide
Other Name: Revlimid®

Drug: Dexamethasone
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®

Biological: Elotuzumab
Other Name: BMS-901608




Primary Outcome Measures :
  1. Change from baseline to progression of the cell surface expression of CS1 from bone marrow-derived MM cells in both treatment arms [ Time Frame: Screening (up to 30 days prior to first dose) and time of progression (33 months) ]

    CS1=CD-2 subset 1

    MM=Multiple Myeloma



Secondary Outcome Measures :
  1. Level of cell surface CS1 from bone marrow-derived MM cells in both treatment arms [ Time Frame: Time of progression (33 months) ]
  2. sCS1 levels in serum and to evaluate change from baseline and during therapy and at progression in both treatment arms [ Time Frame: Screening (up to 30 days prior to first dose), Cycle 3 Day 1 and time of progression (33 months) ]
    sCS1=Soluble form of CS1

  3. The presence, and the change from baseline, on therapy, and at progression, of circulating MM cell numbers and their CS1 cell surface expression in both treatment arms [ Time Frame: Screening (up to 30 days prior to first dose), Cycle 3 Day 1 and time of progression (33 months) ]
  4. The cell number and CS1 expression patterns between matched samples of bone marrow-derived MM cells and circulating MM cells at baseline and at progression in both treatment arms [ Time Frame: Screening (up to 30 days prior to first dose) and time of progression (33 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic MM and who:

  • Have not received any prior systemic anti-myeloma therapy
  • Have measurable disease
  • And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years old. There must be a comorbidity that prevents SCT for a subject <65 years old

Exclusion Criteria:

  • Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
  • Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Active plasma cell leukemia
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891643


Locations
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United States, California
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, Florida
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
United States, Illinois
Illinois Cancercare, Pc
Peoria, Illinois, United States, 61615
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States, 70072
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University Of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
United States, Utah
Northern Utah Associates
Ogden, Utah, United States, 84405
Greece
Local Institution
Athens, Greece, 11528
Italy
Local Institution
Genova, Italy, 16132
Local Institution
Rome, Italy, 00161
Poland
Local Institution
Chorzow, Poland, 41-500
Local Institution
Lublin, Poland, 20-081
Sponsors and Collaborators
Bristol-Myers Squibb
Abbott
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01891643     History of Changes
Other Study ID Numbers: CA204-006 (Biomarker Substudy)
2010-022445-20 ( EudraCT Number )
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Elotuzumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents