A Phase II Study of Daratumumab, Clarithromycin, Pomalido... | NCT04302324

Status Module

Name	Class
Janssen Scientific Affairs, LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
daratumumab/clarithromycin/pomalidomide/dexamethasone	Experimental	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond	Drug: Daratumumab SC Drug: Clarithromycin Drug: Pomalidomide Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Daratumumab SC	Drug	Given as 1800mg via injection	daratumumab/clarithromycin/pomalidomide/dexamethasone

Measure	Description	Time Frame
Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy	Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.	up to end of 8th induction cycle (up to approximately 224 days)

Measure	Description	Time Frame
Progression-Free Survival	Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.	Approximately 3 years
Complete Response Rate or Better

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed Multiple Myeloma
Relapsed and/or refractory myeloma defined as follows: Relapse or progressive disease after at least one previous line of therapy which must include prior daratumumab. At least 8 doses of daratumumab in a previous line must be administered either as monotherapy or in combination with a daratumumab-free interval of ≥3 months AND patient may be daratumumab refractory defined as less than a partial remission (PR) achieved on prior daratumumab-based therapy or have exhibited progression within 60 days of receiving daratumumab. If previous therapy was autologous stem cell transplant (SCT), over 3 months must have elapsed after SCT.
Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
Females of childbearing potential(FCBP) must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of prescribing pomalidomide 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 4 weeks before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Able to take aspirin daily
Life expectancy must be greater than 3 months.
Be able to voluntarily sign and understand written informed consent.
Absolute neutrophil count (ANC) ≥750 cells/mm3 (.75 x 109/L)
Platelets count ≥ 50,000/mm3 (50 x 109/L)
Serum SGOT/AST ≤ 2.0 x upper limits of normal
Serum SGPT/ALT <3.0 x upper limits of normal
Serum creatinine ≤ 2.5 x upper limits of normal
Serum total bilirubin ≤ 1.5 x upper limits of normal (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
All participants must be registered into the mandatory POMALYST REMS™ program and be willing and able to comply with the requirements of the POMALYST REMS™ program.

Exclusion Criteria:

Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies or pomalidomide. Prior pomalidomide exposure in 1 or more previous lines of therapy allowed if partial remission (PR) or better achieved. No disease progression may have occurred within 60 days of receiving pomalidomide.
New York Heart Association (NYHA) Class III or IV heart failure, unstable cardiac arrhythmia, or unstable angina
Myocardial infarction within the past 6 months
Severe obstructive airway disease
Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy
Major surgery within 14 days before enrollment
Radiotherapy within 14 days before enrollment (if area involved is small than within 7 days)
Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
Seropositive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
Patient has greater than Grade 3 peripheral neuropathy, or Grade 2 pain
Participation in other clinical trials within 30 days
History of thromboembolic event within the past 6 months prior to enrollment

Name	Affiliation	Role
Mateo Mejia Saldarriaga, MD	Weill Medical College of Cornell University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medicine - Multiple Myeloma Center		New York	New York	10065	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Mar 26, 2026

Arm/Group Information

ID	Title	Description
BG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants	BG0009

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

Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy

Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.

Posted

Count of Participants

Participants

up to end of 8th induction cycle (up to approximately 224 days)

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants	OG0009

Title

Denominators

Categories

Title	Measurements
	OG0002

Secondary

Progression-Free Survival

Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.

Not Posted

Approximately 3 years

Participants

Secondary

Complete Response Rate or Better

The number of participants with a documented Complete Response (CR) or better, per International Myeloma Working Group (IMWG) criteria.

Posted

Count of Participants

Participants

Approximately 1 year

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants

Secondary

Time to Progression

Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for Progressive Disease

Not Posted

Approximately 3 years

Participants

Secondary

Time to Next Therapy

Measured in months from the date of enrollment to the start date of subsequent treatment for relapsed/refractory multiple myeloma

Not Posted

Approximately 3 years

Participants

Secondary

Duration of Response

Duration of Response (DoR) is defined as the time between the date of initial documentation of best response to the date of first documented evidence of disease progression.

Not Posted

Approximately 3 years

Participants

Secondary

Rate of Minimal Residual Disease (MRD) Negativity

Defined as a number of MRD negative participants

Posted

Count of Participants

Participants

Approximately 8 months

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants	OG000

Secondary

Rate of Improvement in Response During Maintenance Therapy

Percentage of patients that achieved an improved response during maintenance compared to end of induction.

Not Posted

Approximately 3 years

Participants

Secondary

Time to Best Response

Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met criteria for best response per International Myeloma Working Group (IMWG) criteria.

Posted

Median

Full Range

months

Approximately 9.5 months

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants

Secondary

Overall Response Rate

The number of participants with a documented Overall Response (Partial Response or better), per International Myeloma Working Group (IMWG) criteria.

Posted

Count of Participants

Participants

Approximately 1 year

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants

Secondary

Very Good Partial Response (VGPR) Rate or Better

The number of participants with a documented Very Good Partial Response (VGPR) Rate or better, per International Myeloma Working Group (IMWG) criteria.

Posted

Count of Participants

Participants

Approximately 1 year

ID	Title	Description
OG000	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets

Units	Counts
Participants

Secondary

Overall Survival

Overall Survival (OS) is measured in months from the date of enrollment to the date of the participant's death. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier survival estimates.

Not Posted

Approximately 5 years

Participants

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	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone	Induction Phase: 8 cycles (cycle length of 28 days) Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first Pomalidomide 4mg PO on Days 1-21 Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) Daratumumab 1800 mg SC on Day 1 Pomalidomide 4mg PO on Day 1-21 Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets	1	9	6	9	9	9

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonitis	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	COVID	EG0001 events1 affected9 at risk
Hypercalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Respiratory infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Small bowel obstruction	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Atrial Fibrillation	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events1 affected9 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Perforated Diverticulitis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Lung infection	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Strangulated Inguinal hernia	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events1 affected9 at risk
Agitation	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Non-systematic Assessment		EG0005 events3 affected9 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0003 events3 affected9 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Chills	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Cognitive disturbance	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0005 events4 affected9 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0005 events3 affected9 at risk
Respiratory infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment	Covid 19	EG0002 events2 affected9 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Eczema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Eye pain	Eye disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Face edema	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Fatigue	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0005 events5 affected9 at risk
Fever	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Gastroenteritis	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Hypotension	Cardiac disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events1 affected9 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Pain in extremitiy	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0007 events4 affected9 at risk
Lethargy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Lower back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Lymphocyte count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment		EG0006 events4 affected9 at risk
Rash maculo papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0003 events2 affected9 at risk
Malaise	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events1 affected9 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0004 events3 affected9 at risk
Neutrophil count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment		EG00029 events9 affected9 at risk
Non cardiac chest pain	General disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Peripheral neuropathy	Nervous system disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Platelet count decreased	Investigations	CTCAE (4.0)	Non-systematic Assessment		EG0004 events3 affected9 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Retinal detachment	Eye disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Rhinovirus	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0002 events2 affected9 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Non-systematic Assessment		EG0003 events3 affected9 at risk
Urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 at risk
Urinary tract infection	Renal and urinary disorders	CTCAE (4.0)	Non-systematic Assessment		EG0003 events2 affected9 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0003 events2 affected9 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Non-systematic Assessment		EG0001 events1 affected9 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
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Term
D017291	Clarithromycin
C467566	pomalidomide
D003907	Dexamethasone