NCT00445692 · OUTCOME

Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma · Source last updated 2019-11-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: episodes
Interval / dispersion: Not reported
Time frame: First year of therapy

Groups in this outcome

Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

Patients receive clarithromycin orally (PO) twice a day and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given PO Dexamethasone: Given PO Lenalidomide: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	31

Reported measurements

Neutropenia

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	6	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Deep venous thrombus/Pulmonary Embolism

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Anemia

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Pneumonia

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	4	Not reported	Not reported	Not reported	Not reported

Upper respiratory infections

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	12	Not reported	Not reported	Not reported	Not reported

Sinusitis/acute otitis media

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	3	Not reported	Not reported	Not reported	Not reported

Epiglottic appendagitis

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Cellulitis

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	3	Not reported	Not reported	Not reported	Not reported

Clostridium difficile colitis

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Vaginitis

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	3	Not reported	Not reported	Not reported	Not reported

Peripheral neuropathy

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	10	Not reported	Not reported	Not reported	Not reported

Dermal leukocytic vasculitis

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Secondary cancer Acute Myeloid Leukemia

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Re-occurrence of skin cancer

Values in episodes · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
title
Neutropenia
categories
measurements
group Id
OG000
value
1
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
1
title
Deep venous thrombus/Pulmonary Embolism
categories
measurements
group Id
OG000
value
1
title
Anemia
categories
measurements
group Id
OG000
value
4
title
Pneumonia
categories
measurements
group Id
OG000
value
12
title
Upper respiratory infections
categories
measurements
group Id
OG000
value
3
title
Sinusitis/acute otitis media
categories
measurements
group Id
OG000
value
1
title
Epiglottic appendagitis
categories
measurements
group Id
OG000
value
3
title
Cellulitis
categories
measurements
group Id
OG000
value
1
title
Clostridium difficile colitis
categories
measurements
group Id
OG000
value
3
title
Vaginitis
categories
measurements
group Id
OG000
value
10
title
Peripheral neuropathy

denoms

counts
group Id
OG000
value
31
units
Participants

groups

description
Patients receive clarithromycin orally (PO) twice a day and dexamethasone PO once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. Lenalidomide is taken 4 hours or more after last dose of daily clarithromycin. NOTE: \*After one year of treatment, dexamethasone is tapered for an additional 4 weeks. Clarithromycin: Given PO Dexamethasone: Given PO Lenalidomide: Given PO
id
OG000
title
Treatment (Clarithromycin, Dexamethasone, Lenalidomide)

param Type

NUMBER

reporting Status

POSTED

time Frame

First year of therapy

title

Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3

type

PRIMARY

unit Of Measure

episodes

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice