NCT00619684 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-05-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)

→

outcome · POSTED

Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

→

outcome · POSTED

Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide

→

outcome · POSTED

Number 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

→

outcome · POSTED

TTP

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: lenalidomide
label
Treatment (lenalidomide)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (lenalidomide)
description
Given PO
name
lenalidomide
other Names
CC-5013
IMiD-1
Revlimid
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
CR: No Monoclonal Protein (MP) in the blood AND no serum/urine MP by Immunofixation (IF \< 0) AND \< 5% plasma cells in bone marrow aspirate. VGPR: More than 90% decrease of MP and urine M protein \< 100 mg/d OR serum protein electrophoresis (SPEP)/urine protein electrophoresis(UPEP) negative but serum immunofixation (IFs) or IFu urine immunofixation (IFu) ) still positive. PR: Over 50% decrease of serum MP AND \> 90% reduction in 24h urinary light chain excretion or M proteinuria \< 200mg/d MR: Between 25 and 49% decrease of MP in the blood AND 50-89% reduction in 24h urinary light chain excretion (monoclonal proteinuria\>200 mg/d)
measure
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR)
time Frame
Up to 9 years

secondary Outcomes

description
Grade 1-2 adverse events occurring in \>10% of participants. Grade 3 or higher adverse events occurring in one or more participants.
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
description
Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression
measure
Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide
time Frame
Up to 9 years
measure
Number 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
description
Time to Progression (TTP): Time from start of therapy to meeting the definition of Progressive Disease (PD). PD: 25% increase compared to the lowest value of: * Serum MP (absolute increase at least ≥ 0.5 g/dl) * Or: Urine MP (absolute increase at least \> 200 mg/24h) * Or: for patients without measurable MP, Serum Free Light Chain test: the difference between involved and uninvolved FLC levels (absolute increase at least \>100 mg/L)
measure
TTP
time Frame
Up to 9 years
description
Kaplan-Meier estimate of survival
measure
Overall Survival
time Frame
At 1 and 2 years after starting treatment with lenalidomide

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-3448b86f254c6af5ca77
requested nct id
NCT00619684
primary nct id
NCT00619684
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
9bf90210d81a06c50333fa4094be316484b5869d5a0459d3f815432110f1526a
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-3448b86f254c6af5ca77
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00619684
occurrences
context exact
NCT00619684
end
11
exact text
NCT00619684
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/227/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
a8e439c7560c2f2ba00da17ae64da26d63744ec835cf19f74caa37dfbc7a230f
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice