Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Multiple Myeloma - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00114101

Purpose

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may stop or slow the return of cancer. It is not yet known whether lenalidomide is more effective than a placebo when given after autologous stem cell transplant in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying lenalidomide to see how well it works compared to a placebo in treating patients who are undergoing autologous stem cell transplant for multiple myeloma.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: lenalidomide Other: placebo	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Double-Blind, Placebo Control, Randomized, Treatment
Official Title:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to progression [ Designated as safety issue: No ]

Estimated Enrollment:	462
Study Start Date:	December 2004
Estimated Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Maintenance therapy arm I: Experimental Beginning between day 100-110, patients receive oral lenalidomide once daily.	Drug: lenalidomide Given orally
Maintenance therapy arm II: Placebo Comparator Beginning between day 100-110, patients receive oral placebo once daily.	Other: placebo Given orally

Detailed Description:

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.

Secondary

Compare the rate of complete response in patients treated with these regimens.
Compare the progression-free and overall survival of patients treated with these regimens.
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: Patients receive high-dose cyclophosphamide IV over 2-3 hours on day 1 OR IV over 1 hour every 3 hours three times on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 5 and continuing until PBSC collection is complete. Patients then undergo leukapheresis for collection of PBSC.
Autologous PBSC transplantation (PBSCT): Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 30-60 minutes on day -2.

Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on 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 I: Beginning between day 100-110, patients receive oral lenalidomide once daily.
- Arm II: Beginning between day 100-110, patients receive oral placebo once daily.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

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

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 462 patients (231 per maintenance treatment arm) will be accrued for this study within 33 months.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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:

Biologic therapy

Prior thalidomide or lenalidomide allowed provided treatment duration was ≤ 12 months
No prior bone marrow or peripheral blood stem cell transplantation
No concurrent pegfilgrastim

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior solid organ transplantation

Other

Prior therapy allowed provided treatment duration was ≤ 12 months
Peripheral blood stem cell 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114101

Show 96 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Investigator:	Kenneth C. Anderson, MD	Dana-Farber Cancer Institute
Study Chair:	Philip L. McCarthy, MD	Roswell Park Cancer Institute
Study Chair:	Philip R. Greipp, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000434845, CALGB-100104, ECOG-CALGB-100104
Study First Received:	June 13, 2005
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00114101 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Lenalidomide

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Lymphoproliferative Disorders
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Lenalidomide
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on March 13, 2009