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A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

A Multicenter, Single-Arm, Open-Label, Expanded Access Program for Lenalidomide With or Without Dexamethasone in Previously Treated Subjects With Multiple Myeloma


This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study
of lenalidomide as monotherapy or in combination with dexamethasone in subjects with
previously treated relapsed or refractory multiple myeloma, with measurable myeloma
paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were
enrolled into the study. Screening procedures took place within 28 days of first dose.
Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily
for 21 days every 28 days.

Subjects had the following options for dexamethasone treatment at the discretion of the
treating physician:

Option A: No dexamethasone.

Option B: Oral pulse dexamethasone administered at a dose of 40 mg daily on Days 1-4, 9-12,
and 17-20 for each 28-day cycle.

Option C: Oral pulse dexamethasone administered at a dose of 20 mg daily on Days 1-4, 9-12,
and 17-20 for each 28-day cycle.

Option D: Oral dexamethasone administered at a dose of 40 mg weekly on Days 1, 8, 15, and 22
for each 28-day cycle for all cycles. Treatment was to be continued as tolerated until
disease progression developed.

Doses of lenalidomide were allowed to be reduced first from 25 mg to 15 mg and then in 5-mg
decrements due to lenalidomide toxicity. Subjects who could not tolerate a daily dose of 5
mg for 21 days every 28 days were discontinued from treatment. At the discretion of the
investigator, doses of dexamethasone were modified due to dexamethasone toxicity. Dose
reduction and discontinuation schemes for dexamethasone varied according to the treatment
option administered.

Study visits occurred every 2 weeks for the first 3 cycles of therapy and then every 4 weeks
after the third cycle until disease progression was documented, study drug was discontinued
for another reason, or lenalidomide became commercially available for this indication.


Inclusion Criteria:



1. Must understand and voluntarily sign an informed consent form.

2. Must be > or = to 18 years of age at the time of signing the informed consent form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles
of anti-myeloma treatment or that has relapsed with progressive disease after
treatment.

5. Subjects may have been previously treated with thalidomide and/or radiation therapy.
In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given
concurrently with study therapy, provided that all other eligibility criteria are
satisfied.

6. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g
excreted in a 24-hour collection sample).

7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

8. 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 medication.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

2. Pregnant or lactating females.

3. 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.

4. Any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L)

2. Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone
marrow nucleated cells are plasma cells.

3. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone
marrow nucleated cells are plasma cells.

4. Serum creatinine >2.5 mg/dL (221 mmol/L)

5. Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or
serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT]) >3.0 x
upper limit of normal (ULN)

6. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

5. Prior history of malignancies other than multiple myeloma (except for basal cell or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
unless the subject has been free of the disease for >/= 1 year.

6. Known hypersensitivity to thalidomide or dexamethasone.

7. Prior history of uncontrollable side effects to dexamethasone therapy.

8. The development of a desquamating rash while taking thalidomide.

9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of the
initiation of study drug treatment or use of any experimental non-drug therapy (e.g.,
donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study
drug treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.

Outcome Description:

Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.

Outcome Time Frame:

Median time-on-study=18.3 weeks

Safety Issue:

Yes

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MM-016

NCT ID:

NCT00179647

Start Date:

September 2005

Completion Date:

April 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • MM
  • Revlimid
  • CC5013
  • celgene
  • cc-5013
  • relapsed/refractory
  • lenalidomide
  • dexamethasone
  • Decadron
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Marshfield ClinicMarshfield, Wisconsin  54449
Swedish Cancer InstituteSeattle, Washington  98104
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Nevada Cancer CenterLas Vegas, Nevada  89109
Rush Cancer InstituteChicago, Illinois  60612
Kaiser Permanente Medical GroupLos Angeles, California  90027
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Stanford Cancer CenterStanford, California  94305-5824
Siteman Cancer CenterSaint Louis, Missouri  63110
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
SUNY Upstate Medical UniversitySyracuse, New York  13210
Scripps Cancer CenterLa Jolla, California  92037
Deaconess Billings ClinicBillings, Montana  59107-5100
Emory UniversityAtlanta, Georgia  30322
Kaiser Permanente Medical CenterVallejo, California  94589
H Lee Moffitt Cancer CenterTampa, Florida  33612
Mayo ClinicScottsdale, Arizona  
University of Texas Southwestern Medical CenterDallas, Texas  
Wichita CCOPWichita, Kansas  67214-3882
Avera Research InstituteSioux Falls, South Dakota  57105
Methodist Cancer CenterOmaha, Nebraska  68114
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
InterMountain Hematology/OncologySalt Lake City, Utah  84122
Yale University School Of MedicineNew Haven, Connecticut  06520
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Charleston Hematology/Oncology P.A.Charleston, South Carolina  29403
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Alta Bates Cancer CenterBerkeley, California  94704
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Hematology Oncology, PCStamford, Connecticut  06902
Oncology AllianceMilwaukee, Wisconsin  53215
Cedar Sinai Medical CenterDept of MedicineLos Angeles, California  90048
University of ColoradoHealth Science CenterAurora, Colorado  80045-0510
Delaware Clinical & Laboratory Physicians, PANewark, Delaware  19713
University of Miami Medical SchoolMiami, Florida  33136
Gulf Coast OncologySt. Petersburg, Florida  33705
The Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Northwestern University Med CtrDivision of Hem/OncChicago, Illinois  60611-2927
Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research InstituteIndianapolis, Indiana  46202-5254
University of Maryland Medical Center Greenbaum Cancer CtrBaltimore, Maryland  21201-1595
Jackson Oncology AssociatesJackson, Mississippi  39202
Dartmouth Hitchcock Medical Center-Norris Cotton Cancer CenterLebanon, New Hampshire  03756
New York Medical Center, MBCCOPBronx, New York  10466
SUNY Health Science Center - BrooklynBrooklyn, New York  11203
North Shore Hematology/Oncology Associates, PCEast Setauket, New York  11733
NY Presbyterian Hospital/Weill Medical College-Cornell UniversityNew York, New York  10021
Mid Ohio Oncology & Hematology, Inc.Columbus, Ohio  43215
Kaiser Permanente Northwest RegionCenter for Health ResearchPortland, Oregon  97227
South Carolina Oncology AssocColumbia, South Carolina  29210
Medical College of Virginis, North HospitalRichmond, Virginia  23298
Gunderson ClinicLaCrosse, Wisconsin  54601