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A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Phase 3
18 Years
Open (Enrolling)
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant


I. To compare progression-free survival of patients with newly diagnosed multiple myeloma
treated with lenalidomide and low-dose dexamethasone with or without bortezomib.


I. To assess response using the new international response criteria. II. To bank specimens
for future research. III. To assess overall survival and other long-term outcomes stratified
by intent to undergo transplantation at progression.

IV. To verify the reported benefit of bortezomib in promoting bone repair/healing by
comparing and contrasting the bone healing as determined by achievement of MRI-CR (closed as
of 10/15/10).

V. To utilize MRI for accurate baseline staging plus evaluation of response and progression
(closed as of 10/15/10).

VI. To compare achievement of MRI-CR with achievement of x-ray-CR (closed as of 10/15/10).

VII. To evaluate custom and genome-wide single nucleotide polymorphisms (SNPs) in
correlation with biology, prognosis and outcome for both treatment regimens combined.

VIII. To verify the findings recently obtained with the custom BOAC SNP chip on TT2 data
with respect to bone disease in the cooperative group setting.

IX. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic
and risk factors, and response to therapy for both treatment regimens combined.

X. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in
the cooperative group setting.

OUTLINE: Patients are stratified according to the International Staging System (I vs II vs
III) and intent to undergo transplantation at relapse (yes vs no).

INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral dexamethasone once daily on days 1, 8, 15, and 22 and oral
lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12;
oral lenalidomide once daily on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4,
8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.

In both arms, patients who intend to undergo transplantation at relapse undergo peripheral
blood stem cell collection, preferably after course 2.

MAINTENANCE THERAPY: After the completion of at least 4 courses (arm I) or at least 6
courses (arm II) of induction therapy, patients receive maintenance therapy comprising oral
dexamethasone once daily on days 1, 8, 15, and 22 and oral lenalidomide once daily on days
1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable

Patients undergo bone marrow biopsy at baseline and periodically during study for
correlative studies. Patients may also undergo blood sample collection.

After completion of study treatment, patients are followed periodically for up to 6 years.

Inclusion Criteria:

- Newly diagnosed multiple myeloma (MM)

- Stage I, II, or III disease by the New International Staging System

- Measurable disease

- Nonsecretory MM based upon standard M-component criteria (i.e., measurable
serum/urine M-component) is not allowed unless the baseline serum free light chain
level (Freelite™) is elevated

- Serum Freelite must be drawn

- No freelite chains

- Must be offered participation in the Myeloma Specimen Repository for banking and
future research, and in the Gene Expression Profiling (GEP) molecular studies for the
evaluation of genetic polymorphisms

- Must have baseline skeletal survey, including lateral skull, anteroposterior (AP)
pelvis and posteroanterior (PA) chest within 28 days prior to study entry

- Institutions must submit a local cytogenetics report and FISH analysis prior to study

- Zubrod performance status 0-3

- Platelet count ≥ 80,000/mm³*

- ANC ≥ 1,000/mm³*

- Hemoglobin ≥ 9.0 g/dL* (including patients who have been transfused or treated with

- Creatinine clearance > 30 cc/min

- FEV_1 and FVC ≥ 50% of predicted**

- DLCO ≥ 50% of predicted**

- No uncontrolled, active infection requiring IV antibiotics

- No NYHA class III-IV heart failure

- No myocardial infarction within the past 6 months

- No history of treatment for clinically significant ventricular cardiac arrhythmias

- No poorly controlled hypertension

- No poorly controlled diabetes mellitus

- No chronic obstructive or chronic restrictive pulmonary disease

- Must have undergone an EKG within the past month

- No psychiatric illness that could potentially interfere with the completion of study

- No history of cerebral vascular accident with persistent neurologic deficits

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years

- No hepatitis B or C positivity

- HIV negative***

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 4 weeks before, during, and for
4 weeks after study treatment

- Female patients must use 2 reliable forms of contraception simultaneously

- Male patients must use effective barrier contraception

- Patients with pathologic fractures, pneumonia at diagnosis, or symptomatic
hyperviscosity syndrome must have these conditions attended to prior to study entry
(i.e., intramedullary rod, IV antibiotics, or plasmapheresis)

- Patients must have baseline skeletal survey that include lateral skull,
anteroposterior (AP) pelvis, and posteroanterior (PA) chest within the past 28 days

- No prior chemotherapy for this disease

- No prior radiotherapy to a large area of the pelvis (i.e., more than half of the

- No prior bortezomib or lenalidomide

- Prior steroid treatment allowed provided treatment was no more than 2 weeks in

- Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg
subcutaneously daily if allergic to aspirin) as prophylactic coagulation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Evaluated by a one-sided stratified log-rank test.

Outcome Time Frame:

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years

Safety Issue:


Principal Investigator

Brian G. Durie

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group (SWOG) Research Base


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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Bay Area Medical Center Marinette, Wisconsin  54143
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Green Bay Oncology - Oconto Falls Oconto Falls, Wisconsin  54154
Marshfield Clinic at James Beck Cancer Center Rhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Saint Michael's Hospital Stevens Point, Wisconsin  54481
Green Bay Oncology - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
University of Illinois Chicago, Illinois  60612
York Hospital York, Maine  03909
Elkhart Clinic Elkhart, Indiana  46515
Saint Jude Medical Center Fullerton, California  92835
Marin General Hospital Greenbrae, California  94904
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045
Harbin Clinic Medical Oncology and Clinical Research Rome, Georgia  30165
Illinois CancerCare-Bloomington Bloomington%, Illinois  61701
Illinois CancerCare-Canton Canton, Illinois  61520
Illinois CancerCare-Carthage Carthage, Illinois  62321
Illinois CancerCare-Eureka Eureka, Illinois  61530
Illinois CancerCare-Havana Havana, Illinois  62644
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare-Macomb Macomb, Illinois  61455
Illinois CancerCare-Monmouth Monmouth, Illinois  61462
Illinois CancerCare-Community Cancer Center Normal, Illinois  61761
Illinois CancerCare-Pekin Pekin, Illinois  61603
Illinois CancerCare-Peru Peru, Illinois  61354
Illinois CancerCare-Princeton Princeton, Illinois  61356
Illinois CancerCare-Spring Valley Spring Valley, Illinois  61362
Michiana Hematology Oncology PC-Elkhart Elkhart, Indiana  46514
Michiana Hematology Oncology Professional Corporation Indianapolis, Indiana  46601
Michiana Hematology Oncology PC-Plymouth Plymouth, Indiana  46563
Michiana Hematology Oncology PC-South Bend South Bend, Indiana  46601
Michiana Hematology Oncology-PC Westville Westville, Indiana  46391
University of Michigan University Hospital Ann Arbor, Michigan  48109
Michiana Hematology Oncology PC-Niles Niles, Michigan  49120
Lakeside Cancer Specialists PLLC Saint Joseph, Michigan  49085
UMDNJ - New Jersey Medical School Newark, New Jersey  07103
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
Oncology Hematology Associates of Northern Pennsylvania Dubois, Pennsylvania  15801
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Wheaton Franciscan Healthcare - Saint Joseph Milwaukee, Wisconsin  53210
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Aurora Medical Center in Summit Summit, Wisconsin  53066
Vince Lombardi Cancer Clinic Two Rivers, Wisconsin  54241
Arizona Cancer Center at UMC Orange Grove Tucson, Arizona  85704
Kaiser Permanente-Deer Valley Medical Center Antioch, California  94531
Palchak David MD Pismo Beach, California  93449
Kaiser Permanente Medical Center-Vacaville Vacaville, California  95688
Kaiser Permanente-Rock Creek Lafayette, Colorado  80026
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii  96819
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii  96766-1099
Central DuPage Hospital Cancer Center Warrenville, Illinois  60555
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
Salina Regional Health Center. Salina, Kansas  67401
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Cleveland Clinic Cancer Center Beachwood Beachwood, Ohio  44122
Willamette Falls Community Hospital Oregon City, Oregon  97045
University of Tennessee - Memphis Memphis, Tennessee  38163
Memorial Hospital Of Martinsville Martinsville, Virginia  24115
Legacy Salmon Creek Hospital Vancouver, Washington  98686
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
Kaiser Permanente-Franklin Denver, Colorado  80205
UMDNJ - Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin  54848
Roy and Patricia Disney Family Cancer Center Burbank, California  91505
Indiana University Health Goshen Center For Cancer Care Goshen, Indiana  46526
Southwest Oncology Group (SWOG) Research Base San Antonio, Texas  78245
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Community Howard Regional Health Kokomo, Indiana  46904
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Bronson Battle Creek Battle Creek, Michigan  49017
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
Aurora Cancer Care-Southern Lakes Elkhorn, Wisconsin  53121
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin  54601
San Juan Regional Medical Center San Juan, New Mexico  87401
Saint Clare's Hospital Weston, Wisconsin  54476