Expired Study
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Seattle, Washington 98109


Purpose:

This phase II trial studies how well lenalidomide works in treating patients with progressive or recurrent multiple myeloma after a donor stem cell transplant. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate response of relapsed or progressive multiple myeloma to lenalidomide after allogeneic stem cell transplant. II. Proportion of patients achieving a complete, partial or minor response. SECONDARY OBJECTIVES: I. Evaluate toxicity and tolerability of lenalidomide in this setting. II. For patients with chronic graft-versus-host disease (GVHD), evaluate the response to lenalidomide. III. Evaluate time to progression (TTP). IV. Evaluate overall survival (OS). OUTLINE: Patients receive lenalidomide orally (PO) on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.


Criteria:

Inclusion Criteria: - Understand and voluntarily sign an informed consent form - Able to adhere to the study visit schedule and other protocol requirements - Multiple myeloma, having undergone an allogeneic stem cell transplant from a matched or mismatched related or unrelated donor and have relapsed or have disease progression - Relapse is defined as reappearance of monoclonal protein in serum or urine by immunofixation, new or increased bone lesions or hypercalcemia - Disease progression is define as a 25% increase in monoclonal protein in serum or a 50% increase in 24 hour urinary monoclonal protein from the lowest level attained at any time point after allogeneic transplant or new or increased bone lesions or hypercalcemia - All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, excluding corticosteroids for GVHD - Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry - Absolute neutrophil count >= 1.5 x 10^9/L - Platelet count >= 50 x 10^9/L - Serum creatinine =< 2.0 mg/dL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2 x upper limit of normal (ULN) or =< 5 x ULN if hepatic metastases are present - Females of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program; FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide - 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 - Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast - Able to take aspirin 81 or 325 mg daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use Coumadin or low molecular weight heparin) - All study participants must be registered into the mandatory Revlimid REMS™ program, and be willing and able to comply with the requirements of Revlimid REMS™ Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form - Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide) - 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 - Use of any other experimental drug or therapy within 28 days of baseline - Known hypersensitivity to thalidomide - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs - Resistance to prior use of lenalidomide - Concurrent use of other anti-cancer agents or treatments - Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C - Acute GVHD grades 3 or 4


Study is Available At:


Original ID:

2161.00


NCT ID:

NCT00619684


Secondary ID:

NCI-2009-01592


Study Acronym:


Brief Title:

Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant


Official Title:

A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fred Hutchinson Cancer Research Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:William Bensinger
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Dates

Start Date:February 2008
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:August 2015
Primary Completion Type:Actual
Verification Date:September 2015
Last Changed Date:September 28, 2015
First Received Date:February 20, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:OS
Time Frame:Up to 9 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:TTP
Time Frame:Up to 9 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of patients who experience improvement in GVHD on lenalidomide, defined as the reduction in severity of GVHD as defined by the National Institutes of Health (NIH) Consensus Criteria
Time Frame:Up to 9 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Proportion of patients requiring dose interruption, dose reduction or discontinuance of lenalidomide
Time Frame:Up to 9 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame:Up to 30 days after completion of study treatment
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Response rate, defined as the proportion of patients achieving complete response (CR), partial response (PR), or minor response (MR)
Time Frame:Up to 9 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:lenalidomide
Description:Given PO
Arm Name:Treatment (lenalidomide)
Other Name:CC-5013

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (lenalidomide)
Description:Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fred Hutchinson Cancer Research Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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