Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01731886
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 55.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Procedure: Autologous peripheral blood stem cell transplant; Drug: Lenalidomide; Drug: Dexamethasone; Procedure: Stem cell collection; Drug: Melphalan; Drug: G-CSF; Drug: Cyclophosphamide; Drug: Mesna	Phase 4

Detailed Description

Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000 deaths each year in the United States. Approximately one third of myeloma patients develop hypercalcemia and about two thirds present with anemia. As the second most common hematologic malignancy, myeloma remains incurable. In the last forty years, options for therapy have included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with those regimens continues to be inevitable with a median survival of 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
• Actual Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Apr 11, 2017
• Actual Study Completion Date: Apr 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Procedure: Autologous peripheral blood stem cell transplant; Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.; Drug: Lenalidomide; Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.; Other Names: CC-5013 Revlimid ; Drug: Dexamethasone; Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.; Other Names: Decadron Hexadrol Dexameth Dexone DXM ; Procedure: Stem cell collection; Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.; Other Names: Stem Cell Mobilization ; Drug: Melphalan; Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.; Other Names: Evomela ; Drug: G-CSF; Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.; Other Names: Granulocyte-colony stimulating factor (CSF) Filgrastim ; Drug: Cyclophosphamide; Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.; Other Names: Cytophosphane ; Drug: Mesna; Mesna will be provided with the cyclophosphamide.; Other Names: Mesnex
Active Comparator: Arm B Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Drug: Lenalidomide; Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.; Other Names: CC-5013 Revlimid ; Drug: Dexamethasone; Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.; Other Names: Decadron Hexadrol Dexameth Dexone DXM ; Procedure: Stem cell collection; Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.; Other Names: Stem Cell Mobilization ; Drug: Cyclophosphamide; Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.; Other Names: Cytophosphane ; Drug: Mesna; Mesna will be provided with the cyclophosphamide.; Other Names: Mesnex

Outcome Measures

Primary Outcome Measures

1. Complete Response Rate [3 years]

   The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).

Secondary Outcome Measures

1. Overall Survival Rate (OS) [4 years]

   To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

2. Overall Survival Rate (OS) [2 years]

   To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

3. Progression Free Survival (PFS) [4 years]

   PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

4. Progression Free Survival (PFS) [2 years]

   PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.

• Bone marrow plasmacytosis with > or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.

• Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or > 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.

• Age > or = 18 years.

• Life expectancy of greater than 12 months.

• Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 (Karnofsky > or = 60%).

• Adequate organ and marrow function as defined below:

• Hgb > or = 9 g/dL

• Absolute Neutrophil Count > or = 1,500/ ml

• Platelets > or = 50,000/mm3

• Total Bilirubin < or = 1.5 mg/dL

• Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) < or = 2.5 X upper limit of normal (ULN)

• Creatinine < 2.0 mg/dL

• Creatinine Clearance > or = 50 ml/min

• Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.

• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.

• Ability to understand and the willingness to sign a written informed consent document.

• Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months.

• Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended.

• Eligible for transplant with an age up to and including 75 years.

• Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately.

• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom.

Exclusion Criteria:

• Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.

• Receiving any other investigational agents or therapy within 28 days of baseline.

• Brain metastases.

• Subjects who are pregnant or breast feeding.

• History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).

• If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:

• Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).

• Must not have thrombocytopenia requiring transfusion.

• Must have a platelet count > 50,000.

• Must have stable INR between 2-3.

• Smoldering myeloma or monoclonal gammopathy of undetermined significance.

• Active, uncontrolled infection.

• Active, uncontrolled seizure disorder (seizures in the last 6 months).

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

• Positive for HIV or infectious hepatitis, type B or C.

• Hypersensitivity to thalidomide.

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Suzanne Lentzsch, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2015

More Information

Publications

None provided.

• Responsible Party: Suzanne Lentzsch, MD, Associate Clinical Professor of Clinical Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT01731886
• Other Study ID Numbers: AAAJ2355; NCT00777881
• First Posted: Nov 22, 2012
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Suzanne Lentzsch, MD, Associate Clinical Professor of Clinical Medicine, Columbia University: Stem cell transplant; plasma cell myeloma; multiple myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Dexamethasone; Cyclophosphamide; Melphalan; Lenalidomide; Lenograstim

Study Results

Participant Flow

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Autologous peripheral blood stem cell transplant: Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0. Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle. Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle. Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3. Melphalan: Subjects undergoing autologous peripheral blood stem cell transplant will receive	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle. Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle. Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3. Cyclophosphamide: Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously. Mesna: Mesna will be provided with the cyclophosphamide.
Period Title: Overall Study
STARTED	31	29
COMPLETED	29	28
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone	Total
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Total of all reporting groups
Overall Participants	31	29	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 67.7%	18 62.1%	39 65%
>=65 years	10 32.3%	11 37.9%	21 35%
Sex: Female, Male (Count of Participants)
Female	15 48.4%	12 41.4%	27 45%
Male	16 51.6%	17 58.6%	33 55%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 12.9%	6 20.7%	10 16.7%
White	23 74.2%	20 69%	43 71.7%
More than one race	1 3.2%	0 0%	1 1.7%
Unknown or Not Reported	3 9.7%	3 10.3%	6 10%
ISS Stage (Count of Participants)
Stage 1(B2M <3.5 mg/L and serum albumin ≥3.5 g/dL)	11 35.5%	11 37.9%	22 36.7%
Stage 2(Neither stage I nor stage III)	14 45.2%	14 48.3%	28 46.7%
Stage 3(B2M ≥5.5 mg/L)	6 19.4%	4 13.8%	10 16.7%

Outcome Measures

1. Primary Outcome

Title	Complete Response Rate
Description	The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

1 participant in Arm B never started treatment.

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
Measure Participants	31	28
Count of Participants [Participants]	7 22.6%	7 24.1%

2. Secondary Outcome

Title	Overall Survival Rate (OS)
Description	To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
Measure Participants	25	19
Number (95% Confidence Interval) [percentage of participants]	79.8 257.4%	78.9 272.1%

3. Secondary Outcome

Title	Overall Survival Rate (OS)
Description	To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
Measure Participants	25	19
Number (95% Confidence Interval) [percentage of participants]	100 322.6%	94.7 326.6%

4. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
Measure Participants	25	19
Number (95% Confidence Interval) [percentage of participants]	36.0 116.1%	31.6 109%

5. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.

Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation	Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).	Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
Measure Participants	25	19
Number (95% Confidence Interval) [percentage of participants]	52.0 167.7%	47.4 163.4%

Adverse Events

Time Frame	3 years
Arm/Group Title	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation		Arm B: Low-dose Dexamethasone
Arm/Group Description	Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).		Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Only includes subjects who received drug.
All Cause Mortality
	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation		Arm B: Low-dose Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/31 (45.2%)		11/28 (39.3%)
Serious Adverse Events
	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation		Arm B: Low-dose Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/31 (22.6%)		7/28 (25%)
Blood and lymphatic system disorders
Myelodysplastic Syndrome	0/31 (0%)	0	1/28 (3.6%)	2
Cardiac disorders
Presyncope	0/31 (0%)	0	1/28 (3.6%)	1
General disorders
Pain	1/31 (3.2%)	2	0/28 (0%)	0
Abdominal Pain	0/31 (0%)	0	1/28 (3.6%)	1
Back Pain	0/31 (0%)	0	1/28 (3.6%)	1
Syncope	1/31 (3.2%)	1	0/28 (0%)	0
Infections and infestations
Febrile Neutropenia	1/31 (3.2%)	2	0/28 (0%)	0
Infection with Grade 3 or 4 Neutrophils	1/31 (3.2%)	1	1/28 (3.6%)	1
Infection	0/31 (0%)	0	1/28 (3.6%)	1
Lung Infection	1/31 (3.2%)	3	0/28 (0%)	0
Skin Infection	1/31 (3.2%)	1	0/28 (0%)	0
Musculoskeletal and connective tissue disorders
Bone Pain	1/31 (3.2%)	2	1/28 (3.6%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms	1/31 (3.2%)	2	0/28 (0%)	0
Skin and subcutaneous tissue disorders
Pain of skin	0/31 (0%)	0	1/28 (3.6%)	1
Vascular disorders
Thromboembolic Event	0/31 (0%)	0	1/28 (3.6%)	2
Other (Not Including Serious) Adverse Events
	Arm A: Low-dose Dexamethasone + Stem Cell Transplantation		Arm B: Low-dose Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/31 (67.7%)		19/28 (67.9%)
Blood and lymphatic system disorders
Anemia	2/31 (6.5%)	12	4/28 (14.3%)	14
Decreased Neutrophil Count	8/31 (25.8%)	22	4/28 (14.3%)	7
Decreased WBC Count	6/31 (19.4%)	13	3/28 (10.7%)	7
Decreased Platelet Count	5/31 (16.1%)	24	1/28 (3.6%)	1
Abnormal Neutrophils/Granulocytes (ANC/AGC)	5/31 (16.1%)	11	7/28 (25%)	26
Abnormal Leukocytes	2/31 (6.5%)	3	3/28 (10.7%)	8
Abnormal Platelet Count	2/31 (6.5%)	3	4/28 (14.3%)	12
Abnormal Hemoglobin	1/31 (3.2%)	1	3/28 (10.7%)	8
Decreased Lymphocyte Count	0/31 (0%)	0	3/28 (10.7%)	6
Gastrointestinal disorders
Diarrhea	3/31 (9.7%)	7	5/28 (17.9%)	11
General disorders
Pain in extremity	2/31 (6.5%)	3	1/28 (3.6%)	6
Cough	4/31 (12.9%)	7	3/28 (10.7%)	3
Insomnia	3/31 (9.7%)	4	5/28 (17.9%)	7
Paresthesia	0/31 (0%)	0	3/28 (10.7%)	4
Nausea	2/31 (6.5%)	3	2/28 (7.1%)	4
Fatigue	3/31 (9.7%)	4	3/28 (10.7%)	5
Abdominal Pain	2/31 (6.5%)	4	1/28 (3.6%)	1
Hepatobiliary disorders
Increased Alanine Aminotransferase	2/31 (6.5%)	6	2/28 (7.1%)	3
Infections and infestations
Infection	3/31 (9.7%)	5	5/28 (17.9%)	7
Upper Respiratory Infection	1/31 (3.2%)	2	2/28 (7.1%)	3
Urinary Tract Infection	2/31 (6.5%)	3	1/28 (3.6%)	1
Fever	1/31 (3.2%)	2	2/28 (7.1%)	3
Metabolism and nutrition disorders
Hyponatremia	2/31 (6.5%)	3	1/28 (3.6%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder	0/31 (0%)	0	3/28 (10.7%)	4
Skin and subcutaneous tissue disorders
Pruritus	2/31 (6.5%)	3	3/28 (10.7%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.