Know Cancer

or
forgot password

A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 [NSC # 703813, IND #70116] or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 [NSC # 703813, IND #70116] or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma


OBJECTIVES:

Primary

- Compare the efficacy of lenalidomide vs placebo as maintenance therapy after autologous
stem cell transplantation, in terms of prolonging time to disease progression, in
patients with multiple myeloma (arm II closed as of 12/17/09).

Secondary

- Compare the rate of complete response in patients treated with these regimens (arm II
closed as of 12/17/09).

- Compare the progression-free and overall survival of patients treated with these
regimens (arm II closed as of 12/17/09).

- Determine the feasibility of long-term treatment with lenalidomide in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

- Peripheral blood stem cell (PBSC) mobilization: Mobilization of autologous peripheral
blood stem cells will be performed according to institutional guidelines. Stem cells
may be collected at any time prior to transplant.

- Autologous PBSC transplantation (PBSCT): Approximately 2-4 weeks after PBSC collection,
patients receive melphalan IV either over 30-60 minutes on day -2 or as a divided dose
over two days on days -3 and -2 or days -2 and -1. Patients undergo autologous PBSCT on
day 0. Patients receive G-CSF SC once daily after day 0 but before day 5 and continuing
until blood counts recover.

- Maintenance therapy*: Approximately 90-100 days after completion of autologous PBSCT,
patients undergo restaging. Patients with disease progression are removed from the
study. Patients with responding or stable disease are stratified according to levels of
β2 microglobulin at baseline (≥ 2.5 mg/dL vs normal), prior thalidomide (yes vs no),
and prior lenalidomide (yes vs no). Patients are randomized to 1 of 2 maintenance
treatment arms (arm II closed as of 12/17/09).

- Arm I: Beginning between day 100-110, patients receive oral lenalidomide once
daily.

- Arm II (closed as of 12/17/09): Beginning between day 100-110, patients receive
oral placebo once daily. Patients who have not yet met the study endpoint receive
oral lenalidomide as in arm I at the discretion of treating physician.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity (arm II closed as of 12/17/09) .

NOTE: *The maintenance dose is increased to a maximum dose of 3 pills over 3-6 months.

Treatment assignments were unblinded on 12/17/2009. As of 12/17/2009, no more patients will
be randomized between lenalidomide and placebo.

After completion of study treatment, patients are followed every 3 months for 4 years, every
6 months for 5 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 538 will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma

- Active disease requiring treatment

- Durie-Salmon Stage I, II, or III

- Stable disease or responsive after ≥ 2 months of any induction therapy initiated
within the past year

- No prior disease progression after initial therapy

- Patients with smoldering myeloma are eligible provided disease has progressed to ≥
stage I

PATIENT CHARACTERISTICS:

Age

- 18 to 70

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥100,000/mm^3

Hepatic

- Hepatitis B surface antigen negative

- Hepatitis C negative

- Bilirubin ≤ 2 mg/dL

- AST ≤ 3 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 3 times ULN

Renal

- Creatinine clearance ≥ 40 mL/min

- Creatinine ≤ 2 mg/dL

Cardiovascular

- LVEF ≥ 40% by MUGA or echocardiogram

Pulmonary

- DLCO > 50% of predicted

- No symptomatic pulmonary disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception

- HIV negative

- No uncontrolled diabetes mellitus

- No serious active infection

PRIOR CONCURRENT THERAPY:

- Prior thalidomide or lenalidomide allowed provided treatment duration was ≤ 12 months

- No prior bone marrow or peripheral blood stem cell transplantation

- No prior solid organ transplantation

- Prior therapy allowed provided treatment duration was ≤ 12 months

- No more than two prior regimens (not including dexamethasone alone)

- No concurrent pegfilgrastim

- Peripheral blood stem cell (PBSC) collection of ≥ 2 x 10^6 CD34+ cells/kg (patient
body weight) and preferably 5 x 10^6 cells/kg (patient body weight)

- Stem cells may be collected at any time prior to transplant

- PBSC collection may occur before or after registration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000434845

NCT ID:

NCT00114101

Start Date:

December 2004

Completion Date:

July 2019

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Jewish Hospital Cancer CenterCincinnati, Ohio  45236
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Froedtert Hospital and Medical College of WisconsinMilwaukee, Wisconsin  53226-3596
Methodist Medical Center of IllinoisPeoria, Illinois  61636
LDS HospitalSalt Lake City, Utah  84143
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Mountainview MedicalBerlin, Vermont  05602
St. Anthony Central HospitalDenver, Colorado  80204-1335
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Methodist HospitalHouston, Texas  77030
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Galesburg Clinic, PCGalesburg, Illinois  61401
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702
Ralph Lauren Center for Cancer Care and PreventionNew York, New York  10035