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A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-5013
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring CC-5013, CC5013, Revlimid, Lenalidomide, Multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Understand and voluntarily sign an informed consent form. Age greater than 18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. Diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment. Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted in a 24-hour collection sample). Eastern Cooperative Group (ECOG) Performance Status of 0-2. Performance status of 3 and 4 will be allowed if related to bony disease. Bilirubin < 2 x upper limits of normal (ULN). Liver enzymes (ALT or AST) < 3 x ULN. Must have adequate bone marrow function: * Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥ 8 g/dL Must have adequate renal function: creatinine ≤ 2.5 mg/dL. Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose of study drug. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: Severe infection requiring intravenous antibiotic treatment. Life expectancy of less than 3 months. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®. Prior treatment with CC-5013. Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while taking thalidomide. Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking thalidomide. History of cardiac disease, with New York Heart Association Class II or greater. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma. Any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or lactating females. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Sites / Locations

  • Cleveland Clinic Myeloma Program

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2004
Last Updated
November 30, 2016
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00091624
Brief Title
A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)
Official Title
A Phase I Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
CC-5013, CC5013, Revlimid, Lenalidomide, Multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-5013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Understand and voluntarily sign an informed consent form. Age greater than 18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. Diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment. Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted in a 24-hour collection sample). Eastern Cooperative Group (ECOG) Performance Status of 0-2. Performance status of 3 and 4 will be allowed if related to bony disease. Bilirubin < 2 x upper limits of normal (ULN). Liver enzymes (ALT or AST) < 3 x ULN. Must have adequate bone marrow function: * Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥ 8 g/dL Must have adequate renal function: creatinine ≤ 2.5 mg/dL. Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose of study drug. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug. Exclusion Criteria: Severe infection requiring intravenous antibiotic treatment. Life expectancy of less than 3 months. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®. Prior treatment with CC-5013. Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while taking thalidomide. Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking thalidomide. History of cardiac disease, with New York Heart Association Class II or greater. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma. Any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or lactating females. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic Myeloma Program
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24273135
Citation
Lazaryan A, Hussein MA, Reu FJ, Faiman B, Habecker B, Ann Karam M, Reed J, Hamilton K, Waksman J, Bruening K, Srkalovic G, Andresen S, Kalaycio M, Sweetenham JW, Sobecks R, Dean R, Knight R, Zeldis JB, Baz R. Mature results of MM-011: a phase I/II trial of liposomal doxorubicin, vincristine, dexamethasone, and lenalidomide combination therapy followed by lenalidomide maintenance for relapsed/refractory multiple myeloma. Am J Hematol. 2014 Apr;89(4):349-54. doi: 10.1002/ajh.23639. Epub 2014 Feb 24.
Results Reference
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PubMed Identifier
16980599
Citation
Baz R, Walker E, Karam MA, Choueiri TK, Jawde RA, Bruening K, Reed J, Faiman B, Ellis Y, Brand C, Srkalovic G, Andresen S, Knight R, Zeldis J, Hussein MA. Lenalidomide and pegylated liposomal doxorubicin-based chemotherapy for relapsed or refractory multiple myeloma: safety and efficacy. Ann Oncol. 2006 Dec;17(12):1766-71. doi: 10.1093/annonc/mdl313. Epub 2006 Sep 15.
Results Reference
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A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

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