Trial · NCT00091260

CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

NCT00091260, Phase 2, Completed, Vaishali Sanchorawala; results first posted 2017-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis. Trials, record NCT00091260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00091260

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
NCT number: NCT00091260
Status: Completed
Phases: Phase 2
Enrollment: 82 participants, actual
Lead sponsor: Vaishali Sanchorawala
Conditions: Multiple Myeloma
Interventions: dexamethasone, lenalidomide
First posted: 2004-09-09
Last updated: 2017-02-20
Results first posted: 2017-02-20

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients Removed From Study Treatment Due to Toxicities	1 year
Primary	Number of Patients With Hematologic Response With Single-agent CC-5013	3 months	Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine. For patients with an elevated serum free light chain assay, a reduction of 50% or more.
Secondary	Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response	1 year

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients Removed From Study Treatment Due to Toxicities	1 year	Number of patients who had at least one dose of CC-5013	participants	NUMBER
PRIMARY	Number of Patients With Hematologic Response With Single-agent CC-5013	3 months	Participants who received at least 3 cycles of single-agent CC-5013 and underwent subsequent evaluation.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response	1 year		participants	NUMBER

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Patients Removed From Study Treatment Due to Toxicities	Revlimid	31	participants
Number of Patients With Hematologic Response With Single-agent CC-5013	Revlimid	5	Participants
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response	Revlimid	26	participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Revlimid	82
Overall Study	COMPLETED	Revlimid	82
Overall Study	NOT COMPLETED	Revlimid	0

Source ClinicalTrials.gov

Adverse events89

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	neutropenia	Blood and lymphatic system disorders	Revlimid	26	82	32
other	leukopenia	Blood and lymphatic system disorders	Revlimid	21	82	26
other	anemia	Blood and lymphatic system disorders	Revlimid	52	82	53
other	thrombocytopenia	Blood and lymphatic system disorders	Revlimid	27	82	31
other	hypotension	Cardiac disorders	Revlimid	7	82	9
other	Chest pain	Cardiac disorders	Revlimid	7	82	7
other	cardiac, other	Cardiac disorders	Revlimid	5	82	5
other	fatigue	General disorders	Revlimid	54	82	61
other	drowsiness	General disorders	Revlimid	11	82	15
other	Decreased performance status	General disorders	Revlimid	30	82	30

1 to 10 of 89Source ClinicalTrials.gov

See all 89 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Revlimid
Total, other adverse events	Revlimid	82	82
Total, serious adverse events	Revlimid	82	82

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24668858	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00091260

GET https://conductscience.org/api/trials/v1/NCT00091260/events?page=2

API reference For AI assistants