Trial Outcomes & Findings for Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant (NCT NCT00619684)

NCT ID: NCT00619684

Last Updated: 2017-05-18

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Up to 9 years

Results posted on

2017-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Lenalidomide) 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. lenalidomide: Given PO
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 9 years

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) Complete Response (CR)	5 Participants
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) Very Good Partial Response (VGPR)	2 Participants
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) Partial Response (PR)	3 Participants
Response Rate, Defined as the Number of Patients Achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) Minimal Response (MR)	1 Participants

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Grade 1-2 adverse events occurring in \>10% of participants. Grade 3 or higher adverse events occurring in one or more participants.

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 diarrhea	17 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 fever, hypoxia and neuropathy	6 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 constipation	28 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 fatigue	17 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 myalgia	17 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 nausea	11 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 neuropathy	11 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1-2 thrombocytopenia	11 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 pneumonia	17 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 H1N1 influenza	11 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 myalgia	6 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 neuropathy	6 percentage of participants
Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 neutropenia	44 percentage of participants

SECONDARY outcome

Timeframe: Up to 9 years

Population: Patients enrolled on the trial who received lenalidomide treatment.

Dose interruption, dose reduction or discontinuation of lenalidomide due to toxicity, GVHD or disease progression

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
Number of Patients Requiring Dose Interruption, Dose Reduction or Discontinuance of Lenalidomide	13 Participants

SECONDARY outcome

Timeframe: Up to 9 years

Population: Patients who received lenalidomide on study

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
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	0 Participants

SECONDARY outcome

Timeframe: Up to 9 years

Population: Patients who developed Progressive Disease while on lenalidomide treatment

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)

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=10 Participants 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. lenalidomide: Given PO
TTP	8.5 Months Interval 1.2 to 43.0

SECONDARY outcome

Timeframe: At 1 and 2 years after starting treatment with lenalidomide

Population: Patients enrolled on trial who received lenalidomide therapy.

Kaplan-Meier estimate of survival

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide) n=18 Participants 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. lenalidomide: Given PO
Overall Survival Percent Overall Survival at 1 year	71 percentage of participants Interval 43.0 to 87.0
Overall Survival Percent Overall Survival at 2 years	58 percentage of participants Interval 31.0 to 78.0

Adverse Events

Treatment (Lenalidomide)

Serious events: 7 serious events

Other events: 17 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Lenalidomide) n=18 participants at risk 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. lenalidomide: Given PO
Respiratory, thoracic and mediastinal disorders Pneumonia	16.7% 3/18 • Number of events 3 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Respiratory, thoracic and mediastinal disorders Influenza - H1N1	11.1% 2/18 • Number of events 2 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
General disorders Fever, hypoxia, neuralgia	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Nervous system disorders Neuropathy	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.

Other adverse events

Other adverse events
Measure	Treatment (Lenalidomide) n=18 participants at risk 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. lenalidomide: Given PO
Gastrointestinal disorders Diarrhea	16.7% 3/18 • Number of events 3 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
General disorders Fatigue	16.7% 3/18 • Number of events 3 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Psychiatric disorders Depression	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 2/18 • Number of events 2 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Gastrointestinal disorders Anorexia	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Gastrointestinal disorders Nausea	11.1% 2/18 • Number of events 2 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Musculoskeletal and connective tissue disorders Muscle spasm	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Gastrointestinal disorders Constipation	27.8% 5/18 • Number of events 5 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Nervous system disorders Peripheral neuropathy	11.1% 2/18 • Number of events 2 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Skin and subcutaneous tissue disorders Rash	11.1% 2/18 • Number of events 2 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 3/18 • Number of events 3 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
General disorders Fever	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Psychiatric disorders Insomnia	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Ear and labyrinth disorders Epistaxis	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Musculoskeletal and connective tissue disorders Weakness	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Infections and infestations Yeast infection	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Skin and subcutaneous tissue disorders Skin tightness	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Musculoskeletal and connective tissue disorders Jaw popping	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Eye disorders Dry eyes	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.
Gastrointestinal disorders Heartburn	5.6% 1/18 • Number of events 1 • Adverse event followed for 60 days after discontinuation of lenalidomide. Survival follow up up to 4 years.

Additional Information

Dr. William Bensinger

Fred Hutchinson Cancer Research Ctr

Phone: 2066674730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60