Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00540007
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 80
• Locations: 5
• Arms: 2
• Actual Duration (Months): 107.9
• Patients Per Site: 16
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of lenalidomide in the treatment of relapsed or refractory classic Hodgkin lymphoma(cHL).

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Disease	Drug: Lenalidomide	Phase 2

Detailed Description

Hodgkin lymphoma (HL), an uncommon but significant subtype of lymphoma, is divided into classical HL (cHL) and nodular lymphocyte predominant HL (NLPHL). Progress has been made in cHL therapy resulting in 5-year failure free survival rates between 61%-89% even in the setting of advanced stage or bulky disease. Patients who relapse however, have a variable prognosis ranging from a 8-year overall survival rate of less than 8% for patients who never achieve a remission to 54% for patients with a complete remission lasting greater than 12 months. High dose chemotherapy with autologous stem cell support is the standard of care for patients with relapsed cHL but for those that relapse despite aggressive salvage therapy 20 - 50%, with median remission durations of approximately 6 months. Furthermore, a subset of relapsed HL patients may not be candidates for aggressive salvage regimens. These novel salvage therapies are needed for relapsed/refractory cHL, especially agents without serious late toxicities are particularly attractive in this disease. Advances in the understanding of HL pathogenesis and lenalidomide's mechanisms of action provide substantial rationale for evaluating lenalidomide in HL patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma
• Actual Study Start Date: Sep 6, 2007
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 - Lenalidomide daily on days 1-21 The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	Drug: Lenalidomide; Other Names: Revlimid CC-5013
Experimental: Cohort 2 - Lenalidomide daily on days 1-28 The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.	Drug: Lenalidomide; Other Names: Revlimid CC-5013

Outcome Measures

Primary Outcome Measures

1. Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL. [Through 3.5 years from study entry or until disease progression]

   Overall response rate = CR + PR Definitions per 2007 Cheson Lymphoma Response Criteria

Secondary Outcome Measures

1. Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL. [30 days following the completion of treatment]

   Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 The higher the grade the worse the adverse event was considered

2. Cytostatic Overall Response Rate [From 6 months through 3.5 years after study entry]

   Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months Definitions per 2007 Cheson Lymphoma Response Criteria

3. Participant Response Rate in Relapsed or Refractory cHL. [Through 3.5 years from study entry or until disease progression]

   -Definitions per 2007 Cheson Lymphoma Response Criteria

4. Time to Progression (TTP). [Through 3.5 years from study entry or until disease progression]

   -Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.

5. Overall Survival (OS) [Through 3.5 years from study entry or until disease progression]

   Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.

6. Relapse Free Survival (RFS) [Through 3.5 years from study entry or until disease progression]

7. Event Free Survival (EFS). [Through 3.5 years from study entry or until disease progression]

   -Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).

8. Duration of Response [Through 3.5 years from study entry or until disease progression]

   -Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy.

• Patients must have relapsed or progressed after at least one prior systemic cytotoxic chemotherapy; prior autologous or allogeneic stem cell transplantation is allowed.

• Measurable disease must be present either on physical examination or imaging studies (CT, MRI, PET/CT). Any tumor mass greater or equal to 1 cm is acceptable.

• Age > 18 years old.

• ECOG performance status of less than or equal to 2 at study entry

• Adequate hematologic, renal, hepatic function as defined by:

• Absolute neutrophil count greater than or equal to 1000 / uL

• Platelets greater than or equal to 50,000 / uL

• Serum creatinine less than or equal to 1.5X institution upper limit of normal (ULN)

• Total bilirubin less than or equal to 2.0 mg/dL

• AST (SGOT) and ALT (SGPT) less than or equal to 3 x ULN (if not attributed to cHL)

• Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

• Understand and voluntarily sign an informed consent form.

• Able to adhere to the study visit schedule and other protocol requirements

• Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.

• FCBP must have two negative serum or urine pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) 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. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.

• Men must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.

• All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.

• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight

• All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.

Exclusion Criteria:

• Patients who are candidates for high dose chemotherapy and stem cell transplantation and have not yet undergone stem cell transplantation should not be enrolled.

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

• Any condition, including the presence of laboratory abnormalities.

• Use of any other anti-cancer drug or therapy, including experimental, within 30 days of enrollment.

• Known hypersensitivity to thalidomide.

• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

• Any prior use of lenalidomide.

• Known positive for HIV or infectious hepatitis, type A, B or C.

• Pregnant or breastfeeding females.

• Concurrent use of other anti-cancer agents or treatments.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63110
2	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
3	Wake Forest University Medical School	Winston-Salem	North Carolina	United States	27157
4	Ohio State University	Columbus	Ohio	United States	43221
5	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Washington University School of Medicine
• Celgene Corporation

Investigators

• Principal Investigator: Todd Fehniger, M.D., Ph.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

• Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. Review.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00540007
• Other Study ID Numbers: 07-0233 / 201104227
• First Posted: Oct 5, 2007
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Washington University School of Medicine: Hodgkin Lymphoma; Lenalidomide; Anti-neoplastic agents; Thalidomide
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Lenalidomide

Study Results

Participant Flow

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Period Title: Overall Study
STARTED	38	42
COMPLETED	38	42
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28	Total
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.	Total of all reporting groups
Overall Participants	38	42	80
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	34	38	36
Sex: Female, Male (Count of Participants)
Female	22 57.9%	18 42.9%	40 50%
Male	16 42.1%	24 57.1%	40 50%
Region of Enrollment (Count of Participants)
United States	38 100%	42 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.
Description	Overall response rate = CR + PR Definitions per 2007 Cheson Lymphoma Response Criteria
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	42
Number (95% Confidence Interval) [percentage of participants]	21.0 55.3%	28.6 68.1%

2. Secondary Outcome

Title	Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
Description	Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 The higher the grade the worse the adverse event was considered
Time Frame	30 days following the completion of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	42
Neutropenia	18 47.4%	20 47.6%
Leukopenia	11 28.9%	13 31%
Anemia	10 26.3%	4 9.5%
Lymphopenia	9 23.7%	10 23.8%
Thrombocytopenia	7 18.4%	8 19%
Fatigue	3 7.9%	2 4.8%
AST	3 7.9%	1 2.4%
ALT	2 5.3%	1 2.4%
Bilirubin	2 5.3%	2 4.8%
Sensory neuropathy	2 5.3%	0 0%
Dehydration	2 5.3%	0 0%
Infection without neutropenia	2 5.3%	3 7.1%
Infection with neutropenia	1 2.6%	0 0%
Edema	1 2.6%	0 0%
Dyspnea	1 2.6%	0 0%
Pleural effusion	1 2.6%	0 0%
Alkaline phosphatase	1 2.6%	0 0%
Abdominal pain	1 2.6%	0 0%
Low potassium	3 7.9%	3 7.1%
Low sodium	2 5.3%	2 4.8%
Low albumin	1 2.6%	0 0%
Low calcium	1 2.6%	0 0%
High calcium	1 2.6%	0 0%
Low phosphorus	1 2.6%	0 0%
Hearing loss	0 0%	1 2.4%
Thrombosis/embolism	0 0%	1 2.4%
Rash	0 0%	1 2.4%
Febrile neutropenia	1 2.6%	2 4.8%
Pneumonia	0 0%	2 4.8%
High potassium	0 0%	1 2.4%
Hyperuricemia	0 0%	1 2.4%
Confusion	0 0%	1 2.4%
Dizziness	0 0%	1 2.4%
Speech impairment	0 0%	2 4.8%
Chest pain	0 0%	1 2.4%
Extremity pain	0 0%	2 4.8%
Muscle pain	0 0%	1 2.4%
Secondary malignancy - MDS	0 0%	1 2.4%

3. Secondary Outcome

Title	Cytostatic Overall Response Rate
Description	Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months Definitions per 2007 Cheson Lymphoma Response Criteria
Time Frame	From 6 months through 3.5 years after study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	42
Count of Participants [Participants]	15 39.5%	18 42.9%

4. Secondary Outcome

Title	Participant Response Rate in Relapsed or Refractory cHL.
Description	-Definitions per 2007 Cheson Lymphoma Response Criteria
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	42
CR	1 2.6%	3 7.1%
PR	7 18.4%	9 21.4%
SD	13 34.2%	11 26.2%
PD	14 36.8%	14 33.3%
Not evaluable	3 7.9%	4 9.5%
Unknown	0 0%	1 2.4%

5. Secondary Outcome

Title	Time to Progression (TTP).
Description	-Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	40
Median (Inter-Quartile Range) [months]	3.68	4.08

6. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

1 participant was not evaluable in Cohort 1 and 5 participants were not evaluable in Cohort 2 because these participants did not have death dates or last follow-up dates so overall survival cannot be calculated.

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	37	37
Median (95% Confidence Interval) [months]	17.434	23.717

7. Secondary Outcome

Title	Relapse Free Survival (RFS)
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	40
Median (95% Confidence Interval) [months]	3.78	3.93

8. Secondary Outcome

Title	Event Free Survival (EFS).
Description	-Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

2 participants in Cohort 2 were not evaluable because these patients did not have a date of progression, treatment failure, death or last follow-up so RFS could not be calculated.

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	40
Median (95% Confidence Interval) [months]	3.78	3.93

9. Secondary Outcome

Title	Duration of Response
Description	-Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started
Time Frame	Through 3.5 years from study entry or until disease progression

Outcome Measure Data

Analysis Population Description

(2) participants were not evaluable in Cohort 2 because 2 patients did not have progression, death dates, or last follow-up dates so time to progression cannot be calculated.

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21	Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Measure Participants	38	40
Median (Inter-Quartile Range) [months]	3.68	4.08

Adverse Events

Arm/Group Title	Cohort 1 - Lenalidomide Daily on Days 1-21		Cohort 2 - Lenalidomide Daily on Days 1-28
Arm/Group Description	The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.		The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
All Cause Mortality
	Cohort 1 - Lenalidomide Daily on Days 1-21		Cohort 2 - Lenalidomide Daily on Days 1-28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort 1 - Lenalidomide Daily on Days 1-21		Cohort 2 - Lenalidomide Daily on Days 1-28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/38 (23.7%)		10/42 (23.8%)
Cardiac disorders
Left ventricular diastolic dysfunction	0/38 (0%)		1/42 (2.4%)
Chest pain	1/38 (2.6%)		0/42 (0%)
Ear and labyrinth disorders
Hearing loss	0/38 (0%)		1/42 (2.4%)
Eye disorders
Blurred vision	0/38 (0%)		1/42 (2.4%)
Gastrointestinal disorders
Abdominal pain	1/38 (2.6%)		0/42 (0%)
Vomiting	1/38 (2.6%)		0/42 (0%)
General disorders
Fever	2/38 (5.3%)		1/42 (2.4%)
Death NOS	1/38 (2.6%)		0/42 (0%)
General pain	0/38 (0%)		1/42 (2.4%)
Infections and infestations
Infection with normal ANC (pneumonia)	1/38 (2.6%)		1/42 (2.4%)
Febrile neutropenia	0/38 (0%)		1/42 (2.4%)
Infection - lung	0/38 (0%)		1/42 (2.4%)
Investigations
Leukopenia	0/38 (0%)		1/42 (2.4%)
Increased bilirubin	1/38 (2.6%)		0/42 (0%)
Metabolism and nutrition disorders
Dehydration	2/38 (5.3%)		0/42 (0%)
Musculoskeletal and connective tissue disorders
Muscle weakness	1/38 (2.6%)		0/42 (0%)
Arm pain	0/38 (0%)		1/42 (2.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy - MDS	0/38 (0%)		1/42 (2.4%)
Nervous system disorders
Speech impairment	0/38 (0%)		1/42 (2.4%)
Confusion	0/38 (0%)		1/42 (2.4%)
Renal and urinary disorders
Cystitis	0/38 (0%)		1/42 (2.4%)
Reproductive system and breast disorders
Pregnancy	1/38 (2.6%)		0/42 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/38 (2.6%)		0/42 (0%)
Cough	0/38 (0%)		1/42 (2.4%)
Dyspnea	0/38 (0%)		1/42 (2.4%)
Hypoxia	1/38 (2.6%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1 - Lenalidomide Daily on Days 1-21		Cohort 2 - Lenalidomide Daily on Days 1-28
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/38 (100%)		42/42 (100%)
Blood and lymphatic system disorders
Hemoglobin	23/38 (60.5%)		21/42 (50%)
Lymph node pain	1/38 (2.6%)		0/42 (0%)
Cardiac disorders
Chest pain	0/38 (0%)		1/42 (2.4%)
Supraventricular arrhythmia NOS	0/38 (0%)		1/42 (2.4%)
Tachycardia	1/38 (2.6%)		0/42 (0%)
Ear and labyrinth disorders
Ear pain	1/38 (2.6%)		0/42 (0%)
Endocrine disorders
Hypothyroidism	2/38 (5.3%)		2/42 (4.8%)
Night sweats	0/38 (0%)		2/42 (4.8%)
Eye disorders
Conjuctivitis	0/38 (0%)		1/42 (2.4%)
Diplopia	0/38 (0%)		1/42 (2.4%)
Flashing lights	0/38 (0%)		1/42 (2.4%)
Watery eyes	1/38 (2.6%)		0/42 (0%)
Gastrointestinal disorders
Abdominal pain	6/38 (15.8%)		3/42 (7.1%)
Constipation	13/38 (34.2%)		10/42 (23.8%)
Diarrhea	9/38 (23.7%)		7/42 (16.7%)
Distension/bloating	0/38 (0%)		1/42 (2.4%)
Dry mouth	1/38 (2.6%)		1/42 (2.4%)
Dyspepsia/heartburn	0/38 (0%)		1/42 (2.4%)
Dysphagia	1/38 (2.6%)		0/42 (0%)
Esophagus pain	2/38 (5.3%)		1/42 (2.4%)
Flatulence	1/38 (2.6%)		0/42 (0%)
Hemorrhoids	1/38 (2.6%)		0/42 (0%)
Mucositis	3/38 (7.9%)		2/42 (4.8%)
Nausea	14/38 (36.8%)		9/42 (21.4%)
Stomach pain	1/38 (2.6%)		0/42 (0%)
Taste alteration	0/38 (0%)		1/42 (2.4%)
Vomiting	7/38 (18.4%)		2/42 (4.8%)
General disorders
Chest pain	6/38 (15.8%)		4/42 (9.5%)
Chills	3/38 (7.9%)		2/42 (4.8%)
Edema	5/38 (13.2%)		6/42 (14.3%)
Fatigue	19/38 (50%)		18/42 (42.9%)
Fever - no infection	4/38 (10.5%)		4/42 (9.5%)
Flu-like syndrome	5/38 (13.2%)		0/42 (0%)
Sweating	0/38 (0%)		3/42 (7.1%)
Tumor flare	1/38 (2.6%)		0/42 (0%)
Hepatobiliary disorders
Liver dysfunction/failure	1/38 (2.6%)		0/42 (0%)
Infections and infestations
Disseminated cryptococcus	0/38 (0%)		1/42 (2.4%)
Febrile neutropenia	1/38 (2.6%)		1/42 (2.4%)
Infection with neutropenia	2/38 (5.3%)		2/42 (4.8%)
Infection with unknown ANC	0/38 (0%)		1/42 (2.4%)
Infection without neutropenia	12/38 (31.6%)		9/42 (21.4%)
Pneumonia	0/38 (0%)		1/42 (2.4%)
Sinusitis	0/38 (0%)		1/42 (2.4%)
Upper respiratory infection	0/38 (0%)		1/42 (2.4%)
Injury, poisoning and procedural complications
Bruising	0/38 (0%)		2/42 (4.8%)
Investigations
Alkaline phosphatase	11/38 (28.9%)		5/42 (11.9%)
Bilirubin	5/38 (13.2%)		7/42 (16.7%)
Creatinine	6/38 (15.8%)		5/42 (11.9%)
Leukocytes (WBC)	29/38 (76.3%)		32/42 (76.2%)
Lymphopenia	17/38 (44.7%)		21/42 (50%)
Neutrophils (ANC)	25/38 (65.8%)		28/42 (66.7%)
PTT	0/38 (0%)		1/42 (2.4%)
Platelets	21/38 (55.3%)		26/42 (61.9%)
SGOT (AST)	10/38 (26.3%)		8/42 (19%)
SGPT (ALT)	14/38 (36.8%)		9/42 (21.4%)
Weight gain	0/38 (0%)		1/42 (2.4%)
Weight loss	4/38 (10.5%)		4/42 (9.5%)
Metabolism and nutrition disorders
Anorexia	4/38 (10.5%)		5/42 (11.9%)
Dehydration	1/38 (2.6%)		1/42 (2.4%)
High calcium	2/38 (5.3%)		2/42 (4.8%)
High glucose	7/38 (18.4%)		9/42 (21.4%)
High magnesium	0/38 (0%)		1/42 (2.4%)
High potassium	3/38 (7.9%)		2/42 (4.8%)
High sodium	7/38 (18.4%)		0/42 (0%)
Hyperuricemia	0/38 (0%)		1/42 (2.4%)
Hypophosphatemia	2/38 (5.3%)		0/42 (0%)
Low albumin	17/38 (44.7%)		9/42 (21.4%)
Low calcium	11/38 (28.9%)		12/42 (28.6%)
Low glucose	5/38 (13.2%)		2/42 (4.8%)
Low potassium	14/38 (36.8%)		14/42 (33.3%)
Low sodium	12/38 (31.6%)		7/42 (16.7%)
Musculoskeletal and connective tissue disorders
Arthralgia (joint)	6/38 (15.8%)		2/42 (4.8%)
Back pain	5/38 (13.2%)		5/42 (11.9%)
Body aches	0/38 (0%)		1/42 (2.4%)
Diffuse body pain	1/38 (2.6%)		0/42 (0%)
Extremity pain	4/38 (10.5%)		5/42 (11.9%)
Muscle pain	5/38 (13.2%)		4/42 (9.5%)
Muscle weakness	0/38 (0%)		4/42 (9.5%)
Muscle weakness	1/38 (2.6%)		7/42 (16.7%)
Neck pain	4/38 (10.5%)		2/42 (4.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colon polyps	0/38 (0%)		1/42 (2.4%)
Left ovarian cyst	0/38 (0%)		1/42 (2.4%)
Thyroglossal duct cyst	0/38 (0%)		1/42 (2.4%)
Nervous system disorders
Dizziness	1/38 (2.6%)		7/42 (16.7%)
Facial numbness	1/38 (2.6%)		0/42 (0%)
Headache	4/38 (10.5%)		5/42 (11.9%)
Loss of balance	1/38 (2.6%)		0/42 (0%)
Memory impairment	1/38 (2.6%)		1/42 (2.4%)
Neuropathic pain	2/38 (5.3%)		0/42 (0%)
Sensory neuropathy	8/38 (21.1%)		4/42 (9.5%)
Speech impairment	0/38 (0%)		1/42 (2.4%)
Psychiatric disorders
Insomnia	0/38 (0%)		1/42 (2.4%)
Mood alteration - Agitation	1/38 (2.6%)		0/42 (0%)
Mood alteration - Anxiety	1/38 (2.6%)		1/42 (2.4%)
Mood alteration - Depression	2/38 (5.3%)		1/42 (2.4%)
Mood alteration - NOS	1/38 (2.6%)		1/42 (2.4%)
Renal and urinary disorders
Kidney stone	0/38 (0%)		1/42 (2.4%)
Proteinuria	0/38 (0%)		1/42 (2.4%)
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis	11/38 (28.9%)		8/42 (19%)
Cough	12/38 (31.6%)		15/42 (35.7%)
Dyspnea (SOB)	9/38 (23.7%)		9/42 (21.4%)
Pleural effusion	1/38 (2.6%)		0/42 (0%)
Pneumonitis/pulmonary infiltrates	0/38 (0%)		1/42 (2.4%)
Throat pain	0/38 (0%)		1/42 (2.4%)
Voice changes (hoarseness)	0/38 (0%)		1/42 (2.4%)
Wheezing	1/38 (2.6%)		2/42 (4.8%)
Skin and subcutaneous tissue disorders
Abscess	0/38 (0%)		1/42 (2.4%)
Cutaneous horn, left arm	0/38 (0%)		1/42 (2.4%)
Dry skin	5/38 (13.2%)		5/42 (11.9%)
Erythema	0/38 (0%)		2/42 (4.8%)
Paleness	0/38 (0%)		1/42 (2.4%)
Pruritis	7/38 (18.4%)		2/42 (4.8%)
Rash	13/38 (34.2%)		6/42 (14.3%)
Schleraderma	0/38 (0%)		1/42 (2.4%)
Ulceration	0/38 (0%)		1/42 (2.4%)
Vascular disorders
Hypertension	1/38 (2.6%)		0/42 (0%)
Hypotension	1/38 (2.6%)		3/42 (7.1%)
Lymphedema	1/38 (2.6%)		0/42 (0%)
Thrombosis/embolism	0/38 (0%)		1/42 (2.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.