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Multiple MyelomaPhase 3NCT00179647

Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma

A Phase 3 study testing lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene Corporation at 69 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
lenalidomide and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,913 participants
Where
69 sitesin 2 countries
Study dates
Sep 2005to Apr 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must understand and voluntarily sign an informed consent form.
  • Must be > or = to 18 years of age at the time of signing the informed consent form.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • 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.
  • 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.
  • Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g excreted in a 24-hour collection sample).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
  • 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.

Who cannot join

  • 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.
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L)
  • Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Show all 15Show fewer
  • Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow nucleated cells are plasma cells.
  • Serum creatinine >2.5 mg/dL (221 mmol/L)
  • 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)
  • Serum total bilirubin >2.0 mg/dL (34 mmol/L)
  • 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.
  • Known hypersensitivity to thalidomide or dexamethasone.
  • Prior history of uncontrollable side effects to dexamethasone therapy.
  • The development of a desquamating rash while taking thalidomide.
  • 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.

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United States63 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of ColoradoHealth Science Center

    Aurora, Colorado, 80045-0510

  • University of Maryland Medical Center Greenbaum Cancer Ctr

    Baltimore, Maryland, 21201-1595

  • Alta Bates Cancer Center

    Berkeley, California, 94704

  • Center for Cancer And Blood Disorders

    Bethesda, Maryland, 20817

  • Deaconess Billings Clinic

    Billings, Montana, 59102

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • SUNY Health Science Center - Brooklyn

    Brooklyn, New York, 11203

  • Charleston Hematology/Oncology P.A.

    Charleston, South Carolina, 29403

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Hematology-Oncology Associates

    Charlotte, North Carolina, 28203

  • Northwestern University Med CtrDivision of Hem/Onc

    Chicago, Illinois, 60611-2927

  • Rush Cancer Institute

    Chicago, Illinois, 60612-3824

  • South Carolina Oncology Assoc

    Columbia, South Carolina, 29210

  • Mid Ohio Oncology & Hematology, Inc.

    Columbus, Ohio, 43215

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9016

  • Rocky Mountain Cancer Center-Midtown

    Denver, Colorado, 80218

  • North Shore Hematology/Oncology Associates, PC

    East Setauket, New York, 11733

  • Dakota Cancer Institute

    Fargo, North Dakota, 58108-6001

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Univ Cancer Center Bone Marrow Transplantation Program Indiana Cancer Research Institute

    Indianapolis, Indiana, 46202-5254

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7233

  • Gunderson Clinic

    La Crosse, Wisconsin, 54601

  • Scripps Cancer Center

    La Jolla, California, 93037

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Dartmouth Hitchcock Medical Center-Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Cedar Sinai Medical CenterDept of Medicine

    Los Angeles, California, 90048

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • University of Miami Medical School

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Oncology Alliance

    Milwaukee, Wisconsin, 53215

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • St. Vincent's Comprehensive Cancer Center

    New York, New York, 10011

  • NY Presbyterian Hospital/Weill Medical College-Cornell University

    New York, New York, 10021

  • Delaware Clinical & Laboratory Physicians, PA

    Newark, Delaware, 19713

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente Northwest RegionCenter for Health Research

    Portland, Oregon, 97227

  • Medical College of Virginis, North Hospital

    Richmond, Virginia, 23298

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Intermountain Hematology/Oncology

    Salt Lake City, Utah, 84124

  • Kaiser Permanente Medical Group

    San Diego, California, 32120

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • Gulf Coast Oncology

    St. Petersburg, Florida, 33705

  • Hematology Oncology, PC

    Stamford, Connecticut, 06902

  • Stanford Cancer Center

    Stanford, California, 94305-5750

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612-9497

  • New York Medical Center, MBCCOP

    The Bronx, New York, 10466

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • The Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-1023

Other trials in United States

Canada6 sites

  • University of Calgary

    Calgary, Alberta, 2N 4N1

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Dalhousie University Queen Elizabeth II Health Services Centre

    Halifax, Nova Scotia, B3H2Y9

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Princess Margaret Hospital

    Toronto, Ontario, M5J 2M9

  • Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp

    Vancouver, British Columbia, V5Z 4E3

Other trials in Canada

About this study

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

Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for the indication of multiple myeloma.

Read the detailed description

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.

Keywords
Multiple Myeloma, MM, Revlimid, CC5013, celgene, cc-5013, relapsed/refractory, lenalidomide, dexamethasone, Decadron
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called Revlimid

    Lenalidomide, 5 mg to 25 mg, QD, orally, for 21 days every 28 days, with or without dexamethasone

  • dexamethasoneDrug

    Also called Decadron

    Dexamethasone, 20 mg to 40 mg, QD, orally, administered under a variety of dosing regimens

Study groups in NCT00179647
Study groupRoleWhat they receive
Lenalidomide 5-25 mg, w/wo dexamethasoneOthersingle-arm, open-label, lenalidomide, 5-25 mg, 21/28 days, with/without dexamethasone
Receives: Drug: lenalidomide; Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Median time-on-study=18.3 weeks

  2. Overall Incidence of Adverse Events

    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.

    Measured: Median time-on-study=18.3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2008
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,913 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179647
Sponsor's protocol ID
CC-5013-MM-016
Status last verified
Mar 2010
First submitted
13 Sep 2005
Last updated
16 Mar 2010
Data monitoring committee
No
Expanded access
Available

Publications

  • Reece D, Song KW, Fu T, Roland B, Chang H, Horsman DE, Mansoor A, Chen C, Masih-Khan E, Trieu Y, Bruyere H, Stewart DA, Bahlis NJ. Influence of cytogenetics in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone: adverse effect of deletion 17p13. Blood. 2009 Jul 16;114(3):522-5. doi: 10.1182/blood-2008-12-193458. Epub 2009 Mar 30.

    PubMed 19332768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene Corporation at 69 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment. (time frame: Median time-on-study=18.3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00179647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2010.

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