Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld... | NCT00807599

Name	Class
Tufts Medical Center	OTHER
Lahey Clinic	OTHER

Label	Type	Description	Intervention Names
Stem cell transplant x 1 or x 2	Experimental	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.	Procedure: Stem cell transplant x 1 or x 2
Continue lenalidomide and dexamethasone	Experimental	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time.	Drug: lenalidomide and dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Stem cell transplant x 1 or x 2	Procedure	After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Measure	Description	Time Frame
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.		2 years

Measure	Description	Time Frame
Number of Participants With VGPR + CR Rate	VGPR/Very Good Partial Response + CR/Complete Response (>/= VGPR) for each study arm Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and ≤ 75
Histologic and serologic findings from MSKCC confirming the diagnosis of multiple myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the revised International Myeloma Working Group diagnostic criteria.
Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma). If immediate therapy with radiation and high-dose steroids (eg, for cord compression) or with bortezomib-based therapy (eg, for renal failure) is required, the patient is not eligible for this trial.
Patients may have received 1 cycle of prior therapy with dexamethasone for multiple myeloma.
Adequate organ function is required, defined as follows:
ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due to multiple myeloma)
Serum bilirubin ≤ 2.0 mg/dl
AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of CrCl (see Appendix I): Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
Performance status (ECOG) ≤ 2 (Appendix E).
Eligible for SCT with LVEF ≥ 50% by MUGA or ECHO, and diffusing capacity > 50% predicted by pulmonary function testing
Ability to understand the investigational nature of this study and to give informed consent
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements the of Revlimid REMS® program
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide for cycle 1 (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 not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Able to take aspirin 325mg or 81mg daily as prophylactic anticoagulation (patients intolerant to ASA may use Coumadin or low molecular weight heparin).

Exclusion Criteria:

Prior treatment for myeloma except for one cycle of dexamethasone
History of thromboembolic disease within the past 6 months regardless of anticoagulation
Myocardial infarction within 6 months prior to enrollment, or New York Hospital Association (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Pregnant or breast-feeding women are excluded due to the potential teratogenicity of lenalidomide.
Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insitu of the cervix, or presence of myelodysplastic or myeloproliferative disease. Patients with prior malignancies with a disease-free interval of ≥ 5 years are eligible.
Patients who have had prior malignancies within the past 5 years but are considered to be "cured" with a low likelihood of recurrence may be eligible at the discretion of the Principal Investigator.
Active hepatitis B or C infection
HIV 1 or 2 positivity
Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

Name	Affiliation	Role
Hani Hassoun, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memoral Sloan Kettering Cancer Center		Basking Ridge	New Jersey		United States
Memorial Sloan-Kettering Cancer Center @ Suffolk

Label	URL
Memorial Sloan Kettering Cancer Center	View source

ID	Title	Description
FG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 13, 2018

Arm/Group Information

ID	Title	Description
BG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
BG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00124 BG00250

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.

Posted

Number

95% Confidence Interval

percentage of participants

2 years

ID	Title	Description
OG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
OG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Units	Counts
Participants	OG00026 OG00124

Title

Denominators

Categories

Title	Measurements
	OG00084.6(70.7 to 98.5) OG00183.3(68.4 to 98.2)

Secondary

Number of Participants With VGPR + CR Rate

VGPR/Very Good Partial Response + CR/Complete Response (>/= VGPR) for each study arm

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
OG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Secondary

Overall Response Rates

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
OG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Secondary

Overall Survival

Posted

Number

95% Confidence Interval

percentage of participants alive

up to 4 years

ID	Title	Description
OG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
OG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Continue Lenalidomide and Dexamethasone	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone saving stem cell transplant for a later time. lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.	3	26	17	26	26	26
EG001	Stem Cell Transplant x 1 or x 2	All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either : stem cell transplant right after collection continue lenalidomide and dexamethasone, saving stem cell transplant for a later time. Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization. On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.	5	24	18	24	24	24

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected26 at risk EG0011 affected24 at risk
Blood Glucose Increase	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Cardiac disorder	Cardiac disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Cardiac Valve Disease	Cardiac disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Catheter related infection	Infections and infestations	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Chest pain	Cardiac disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0004 affected26 at risk EG0014 affected24 at risk
Hemoglobin decreased	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected26 at risk EG0012 affected24 at risk
Infection	Infections and infestations	Systematic Assessment	EG0001 affected26 at risk EG0016 affected24 at risk
Myelodysplasia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Myocardial ischemia	Cardiac disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0003 affected26 at risk EG0011 affected24 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Pain	General disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Peripheral ischemia	Vascular disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 affected26 at risk EG0014 affected24 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Serum sodium decrease	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Soft tissue necrosis lower limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected26 at risk EG0010 affected24 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 affected26 at risk EG0011 affected24 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0002 affected26 at risk EG0012 affected24 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0005 affected26 at risk EG0016 affected24 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Flu-like symptoms	General disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
INR increased	Investigations	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Joint pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Mental Status	General disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Skin disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk
Visceral arterial ischemia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0011 affected24 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ALT	Investigations	Systematic Assessment	EG0003 affected26 at risk EG0019 affected24 at risk
AST	Investigations	Systematic Assessment	EG0003 affected26 at risk EG0015 affected24 at risk
Alkaline Phosphatase	Investigations	Systematic Assessment	EG0001 affected26 at risk EG0013 affected24 at risk
Bilirubin	Investigations	Systematic Assessment	EG0003 affected26 at risk EG0013 affected24 at risk
CPK	Investigations	Systematic Assessment	EG0003 affected26 at risk EG0011 affected24 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 affected26 at risk EG0012 affected24 at risk
Creatinine	Investigations	Systematic Assessment	EG0004 affected26 at risk EG0011 affected24 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0003 affected26 at risk EG0014 affected24 at risk
Edema: limb	General disorders	Systematic Assessment	EG0002 affected26 at risk EG0010 affected24 at risk
Fatigue	General disorders	Systematic Assessment	EG0009 affected26 at risk EG00110 affected24 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00017 affected26 at risk EG00113 affected24 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected26 at risk EG0011 affected24 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00020 affected26 at risk EG00119 affected24 at risk
INR	Investigations	Systematic Assessment	EG0004 affected26 at risk EG0013 affected24 at risk
Infection, other	Infections and infestations	Systematic Assessment	EG0001 affected26 at risk EG0015 affected24 at risk
White Blood Cell	Investigations	Systematic Assessment	EG00023 affected26 at risk EG00122 affected24 at risk
Lymphopenia	Investigations	Systematic Assessment	EG00023 affected26 at risk EG00122 affected24 at risk
Magnesium	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected26 at risk EG0010 affected24 at risk
Neuropathy: Sensory	Nervous system disorders	Systematic Assessment	EG0004 affected26 at risk EG0014 affected24 at risk
Neutrophils/Granulocytes	Investigations	Systematic Assessment	EG00024 affected26 at risk EG00121 affected24 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 affected26 at risk EG0010 affected24 at risk
Pain - Joint	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected26 at risk EG0012 affected24 at risk
Pain, Other	General disorders	Systematic Assessment	EG0008 affected26 at risk EG0016 affected24 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG00015 affected26 at risk EG00117 affected24 at risk
Platelets	Investigations	Systematic Assessment	EG00017 affected26 at risk EG00121 affected24 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0005 affected26 at risk EG0012 affected24 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected26 at risk EG0017 affected24 at risk
Rash Desquamation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected26 at risk EG0010 affected24 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 affected26 at risk EG0013 affected24 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected26 at risk EG0016 affected24 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected26 at risk EG0013 affected24 at risk
Febrile Neuropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected26 at risk EG0012 affected24 at risk
Fever	General disorders	Systematic Assessment	EG0000 affected26 at risk EG0014 affected24 at risk
Pain - Pelvis	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected26 at risk EG0012 affected24 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected26 at risk EG0012 affected24 at risk
Blurred Vision	Eye disorders	Systematic Assessment	EG0000 affected26 at risk EG0012 affected24 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000084862	Drug Tapering
D000375	Aging
D000077269	Lenalidomide
D003907	Dexamethasone
D004361	Drug Tolerance
D013812	Therapeutics

ID	Term
D004358	Drug Therapy
D048788	Growth and Development
D010829	Physiological Phenomena
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D000069437	Pharmacological Phenomena
D002620	Pharmacological and Toxicological Phenomena