Trial · NCT00098475

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

NCT00098475, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2014-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma. Trials, record NCT00098475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098475

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Trial

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

Title: Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma
NCT number: NCT00098475
Status: Active not recruiting
Phases: Phase 3
Enrollment: 452 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: DS Stage I Multiple Myeloma, DS Stage II Multiple Myeloma, DS Stage III Multiple Myeloma
Interventions: Dexamethasone, Laboratory Biomarker Analysis, Lenalidomide, Thalidomide
First posted: 2004-12-08
Last updated: 2026-08-28
Results first posted: 2014-01-22

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With Objective Response (First Phase, Step 1)	Assessed every 4 weeks for 16 weeks during Step 1	Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.
Secondary	Proportion of Patients With Objective Response (First Phase, Step 2)	Assessed every 4 weeks for 16 weeks during Step 2	Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response). As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With Objective Response (First Phase, Step 1)	Assessed every 4 weeks for 16 weeks during Step 1	Only eligible patients were included in this analysis.	Proportion of patients	NUMBER
SECONDARY	Proportion of Patients With Objective Response (First Phase, Step 2)	Assessed every 4 weeks for 16 weeks during Step 2	Only eligible patients were included in this analysis.	Proportion of patients	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Proportion of Patients With Objective Response (First Phase, Step 1)	Arm I (Lenalidomide, Dexamethasone)	0.79	95% Confidence Interval 0.729 to 0.842	Proportion of patients
Proportion of Patients With Objective Response (First Phase, Step 1)	Arm II (Lenalidomide, Low-dose Dexamethasone)	0.683	95% Confidence Interval 0.615 to 0.745	Proportion of patients
Proportion of Patients With Objective Response (First Phase, Step 2)	Arm I (Lenalidomide, Dexamethasone)	0	95% Confidence Interval 0.0 to 0.842	Proportion of patients
Proportion of Patients With Objective Response (First Phase, Step 2)	Arm II (Lenalidomide, Low-dose Dexamethasone)	0	95% Confidence Interval 0.0 to 0.336	Proportion of patients

Source ClinicalTrials.gov

Participant flow40

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

Period	Milestone	Group	Participants
Step 1	STARTED	Arm I (Lenalidomide, Dexamethasone)	223
Step 1	STARTED	Arm II (Lenalidomide, Low-dose Dexamethasone)	222
Step 1	STARTED	Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)	4
Step 1	STARTED	Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)	3
Step 1	Treated	Arm I (Lenalidomide, Dexamethasone)	223
Step 1	Treated	Arm II (Lenalidomide, Low-dose Dexamethasone)	220
Step 1	Treated	Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)	4
Step 1	Treated	Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)	3
Step 1	Eligible	Arm I (Lenalidomide, Dexamethasone)	214
Step 1	Eligible	Arm II (Lenalidomide, Low-dose Dexamethasone)	208

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events1,212

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
other	Fatigue	General disorders	Arm I (Lenalidomide, Dexamethasone) Step 1	132	223
other	Fatigue	General disorders	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1	136	220
other	Fatigue	General disorders	Arm I (Lenalidomide, Dexamethasone) Step 2	2	4
other	Fatigue	General disorders	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2	10	14
other	Fatigue	General disorders	Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)	3	4
other	Fatigue	General disorders	Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)	1	3
other	Fever w/o neutropenia	General disorders	Arm I (Lenalidomide, Dexamethasone) Step 1	23	223
other	Fever w/o neutropenia	General disorders	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1	12	220
other	Fever w/o neutropenia	General disorders	Arm I (Lenalidomide, Dexamethasone) Step 2	0	4
other	Fever w/o neutropenia	General disorders	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2	0	14

1 to 10 of 1,212Source ClinicalTrials.gov

See all 1,212 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Lenalidomide, Dexamethasone) Step 1
Total, all-cause mortality	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1
Total, all-cause mortality	Arm I (Lenalidomide, Dexamethasone) Step 2
Total, all-cause mortality	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2
Total, all-cause mortality	Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)
Total, all-cause mortality	Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)
Total, other adverse events	Arm I (Lenalidomide, Dexamethasone) Step 1	222	223
Total, other adverse events	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1	216	220
Total, other adverse events	Arm I (Lenalidomide, Dexamethasone) Step 2	4	4
Total, other adverse events	Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2	14	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19853510	DERIVED	PubMed
21860025	DERIVED	PubMed
23422747	DERIVED	PubMed

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180820	ECOG-ACRIN Network Group Operations Center	ODwyer, Peter J; SCHNALL, MITCHELL D.	ECOG-ACRIN MEDICAL RESEARCH FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

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/NCT00098475

GET https://conductscience.org/api/trials/v1/NCT00098475/flow?page=2

API reference For AI assistants