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DS Stage I Multiple MyelomaPhase 3NCT00098475

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

A Phase 3 study testing Dexamethasone, Laboratory Biomarker Analysis and Lenalidomide in people with DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma, run by National Cancer Institute (NCI) at 138 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone, Laboratory Biomarker Analysis and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
138 sitesUnited States
Study dates
3 Nov 2004to 23 Oct 2026
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

  • Patients must be diagnosed with symptomatic multiple myeloma within the past 90 days confirmed by the following:
  • Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma which must be obtained within 4 weeks prior to randomization
  • Measurable levels of monoclonal protein (M protein): >= 1.0 g/dL on serum protein electrophoresis or >= 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to randomization; both serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP) are required to be performed within 28 days prior to randomization; please note that if both serum and urine m-components are present, both must be followed in order to evaluate response
  • Hemoglobin > 7 g/dL
  • Platelet count > 75,000 cells/mm^3
  • Absolute neutrophil count > 1000 cells/mm^3
Show all 13Show fewer
  • Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) >= 60 mL/min
  • Bilirubin =< 1.5 mg/dL
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times the upper limit of normal
  • Prior palliative and/or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to date of registration; patients with prior solitary plasmacytoma treated with radiation therapy with curative intent are eligible if the disease has now progressed to active multiple myeloma meeting all the eligibility criteria for this protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method (intrauterine device [IUD], birth control pills, tubal ligation or partner's vasectomy) and one additional effective method (condom, diaphragm or cervical cap); FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy starting 4 weeks prior to and while taking CC5013 or thalidomide and for four weeks after discontinuing this therapy; a FCBP is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
  • Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months

Who cannot join

  • No prior systemic therapy with the exception of bisphosphonates for multiple myeloma
  • Prior glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted; prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day; prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted
  • Patients must not have active, uncontrolled seizure disorder; patients must have had no seizures in the last 6 months
  • Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson syndrome
  • Patients with smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible
  • Patients must not have grade 2 or higher peripheral neuropathy due to other medical conditions at the time of randomization
Show all 11Show fewer
  • Patients must not have active, uncontrolled infection
  • Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
  • For patients registered prior to activation of Addendum # 6; patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or Coumadin
  • For patients registered after activation of Addendum # 6; patients entering the expansion phase of the protocol, which tests anticoagulant prophylaxis, must be able and willing to be randomized between aspirin at 325 mg/day and Coumadin
  • Female patients MUST NOT be pregnant or breastfeeding; due to the potential teratogenic properties of CC 5013, and the known teratogenicity associated with thalidomide, the use of these drugs in this patient population is ABSOLUTELY CONTRAINDICATED

Trial locations and contacts

138 sites in 1 country.

138 sites in 1 country

United States138 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Atlanta Regional CCOP

    Atlanta, Georgia, 30342

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Sentara Martha Jefferson Hospital

    Charlottesville, Virginia, 22911

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Ascension Alexian Brothers - Elk Grove Village

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Jude Medical Center

    Fullerton, California, 92835

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Duly Health and Care Joliet

    Joliet, Illinois, 60435

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • IU Health Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • HealthAlliance Hospital - Leominster

    Leominster, Massachusetts, 01453

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Centra Alan B Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

  • Atrium Health Navicent

    Macon, Georgia, 31201

  • SSM Health Dean Medical Group - South Madison Campus

    Madison, Wisconsin, 53715

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • El Camino Hospital

    Mountain View, California, 94040

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Mount Sinai Union Square

    New York, New York, 10003

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple Health - Chestnut Hill Hospital

    Philadelphia, Pennsylvania, 19118

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania, 19141

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Swedish American Hospital

    Rockford, Illinois, 61104

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Kaiser Permanente-Rio San Diego

    San Diego, California, 92108

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • Grand View Hospital

    Sellersville, Pennsylvania, 18960

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Edward H Kaplan MD and Associates

    Skokie, Illinois, 60076

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Martin Hospital South

    Stuart, Florida, 34997

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • MercyOne Waterloo Cancer Center

    Waterloo, Iowa, 50702

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Southeast Clinical Oncology Research Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the response rate and toxicity of lenalidomide (CC-5013) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase).

SECONDARY OBJECTIVES:

  1. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase).

II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase).

III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase).

IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio [INR] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively.

Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both salvage therapy arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

Being tested
Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide, Thalidomide

What participants receive

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

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Laboratory Biomarker AnalysisOther

    Optional correlative studies

  • LenalidomideDrug

    Also called CC 5013, CC-5013, CC5013, CDC 501

    Given PO

  • ThalidomideDrug

    Also called (+)-Thalidomide, (-)-Thalidomide, .alpha.-Phthalimidoglutarimide, 2, 6-Dioxo-3-phthalimidopiperidine

    Given PO

Study groups in NCT00098475
Study groupRoleWhat they receive
Arm I (lenalidomide, dexamethasone)Active comparatorPatients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.
Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide
Arm II (lenalidomide, low-dose dexamethasone)ExperimentalPatients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide
Arm III (thalidomide, dexamethasone)Active comparatorPatients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20
Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Thalidomide
Arm IV (thalidomide, low-dose dexamethasone)ExperimentalPatients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.
Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Thalidomide

What is being measured

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

  1. Proportion of Patients With Objective Response (First Phase, Step 1)

    Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).

    As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

    Measured: Assessed every 4 weeks for 16 weeks during Step 1

Secondary outcomes (1)

  1. Proportion of Patients With Objective Response (First Phase, Step 2)

    Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).

    As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

    Measured: Assessed every 4 weeks for 16 weeks during Step 2

Timeline

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

  1. First posted8 Dec 2004 (estimated)
  2. Study start3 Nov 2004
  3. Primary completion30 Nov 2008
  4. Study completion23 Oct 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098475
Sponsor's protocol ID
NCI-2012-03150
Other IDs
NCI-2012-03150, E4A03, CDR0000404161, E4A03, E4A03, U10CA180820, U10CA021115
Status last verified
Apr 2026
First submitted
7 Dec 2004
Last updated
28 Aug 2026
Data monitoring committee
Yes

Publications

  • Baker A, Braggio E, Jacobus S, Jung S, Larson D, Therneau T, Dispenzieri A, Van Wier SA, Ahmann G, Levy J, Perkins L, Kim S, Henderson K, Vesole D, Rajkumar SV, Jelinek DF, Carpten J, Fonseca R. Uncovering the biology of multiple myeloma among African Americans: a comprehensive genomics approach. Blood. 2013 Apr 18;121(16):3147-52. doi: 10.1182/blood-2012-07-443606. Epub 2013 Feb 19.

    PubMed 23422747

  • Kumar SK, Uno H, Jacobus SJ, Van Wier SA, Ahmann GJ, Henderson KJ, Callander NS, Haug JL, Siegel DS, Greipp PR, Fonseca R, Rajkumar SV. Impact of gene expression profiling-based risk stratification in patients with myeloma receiving initial therapy with lenalidomide and dexamethasone. Blood. 2011 Oct 20;118(16):4359-62. doi: 10.1182/blood-2011-03-342089. Epub 2011 Aug 22.

    PubMed 21860025

  • Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37. doi: 10.1016/S1470-2045(09)70284-0. Epub 2009 Oct 21.

    PubMed 19853510

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone, Laboratory Biomarker Analysis and Lenalidomide in people with DS Stage I Multiple Myeloma and DS Stage II Multiple Myeloma, run by National Cancer Institute (NCI) at 138 sites in United States.

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 13 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States. 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 22 Jan 2014). 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?

Proportion of Patients With Objective Response (First Phase, Step 1) (time frame: Assessed every 4 weeks for 16 weeks during Step 1). 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 NCT00098475, which also lists 3 linked publications.

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 28 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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