Trial · NCT00075829

Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)

NCT00075829, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2016-08-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102). Trials, record NCT00075829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075829

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Trial

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

Title: Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102)
NCT number: NCT00075829
Status: Completed
Phases: Phase 3
Enrollment: 710 participants, actual
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Conditions: Multiple Myeloma
Interventions: One Autologous Transplant, Non-Myeloablative Allogeneic Transplant, Second Autologous Transplant, Thalidomide, Dexamethasone, Observation
First posted: 2004-01-13
Last updated: 2021-11-01
Results first posted: 2016-08-04

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS)	Year 3	Patients are considered a failure for this endpoint if they die or if they progress or relapse.
Secondary	Overall Survival (OS) for Standard Risk	Years 1, 2, and 3	The event is death from any cause, patients alive at the time of last observation are considered censored.
Secondary	Overall Survival (OS) for High Risk	Year 3	The event is death from any cause, patients alive at the time of last observation are considered censored.
Secondary	Cumulative Incidence of Progression/Relapse	Year 3	Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.
Secondary	Cumulative Incidence of Treatment Related Mortality (TRM)	Year 3	TRM is defined as death occurring in a patient from causes other than relapse or progression.
Secondary	Interval From First to Second Transplantation	Year 1	Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.
Secondary	Incidences of Graft Versus Host Disease (GVHD)	Day 100	Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.
Secondary	Incidences of Chronic GVHD	Years 1 and 2	Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS)	Year 3	Patients that completed second transplant	percentage of patients	NUMBER
SECONDARY	Overall Survival (OS) for Standard Risk	Years 1, 2, and 3	Patients that completed second transplant	percentage of patients	NUMBER
SECONDARY	Overall Survival (OS) for High Risk	Year 3	Patients that completed second transplant	percentage of participants	NUMBER
SECONDARY	Cumulative Incidence of Progression/Relapse	Year 3	Patients that completed second transplant	percentage of patients	NUMBER
SECONDARY	Cumulative Incidence of Treatment Related Mortality (TRM)	Year 3	Patients that completed second transplant	percentage of participants	NUMBER
SECONDARY	Interval From First to Second Transplantation	Year 1	Patients that completed second transplant	days	MEDIAN
SECONDARY	Incidences of Graft Versus Host Disease (GVHD)	Day 100	GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant	percentage of patients	NUMBER
SECONDARY	Incidences of Chronic GVHD	Years 1 and 2	GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival (PFS)	Auto-Auto Standard Risk		46	95% Confidence Interval 42 to 51	percentage of patients
Progression-Free Survival (PFS)	Auto-Allo Standard Risk		43	95% Confidence Interval 36 to 51	percentage of patients
Progression-Free Survival (PFS)	Auto-Auto High Risk		33	95% Confidence Interval 22 to 50	percentage of patients
Progression-Free Survival (PFS)	Auto-Allo High Risk		40	95% Confidence Interval 27 to 60	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Auto Standard Risk	1 year	95	95% Confidence Interval 93 to 97	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Allo Standard Risk	1 year	91	95% Confidence Interval 87 to 95	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Auto Standard Risk	2 years	89	95% Confidence Interval 86 to 92	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Allo Standard Risk	2 years	85	95% Confidence Interval 80 to 91	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Auto Standard Risk	3 years	80	95% Confidence Interval 77 to 84	percentage of patients
Overall Survival (OS) for Standard Risk	Auto-Allo Standard Risk	3 years	77	95% Confidence Interval 72 to 84	percentage of patients

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Auto-Auto Standard Risk	436
Overall Study	STARTED	Auto-Allo Standard Risk	189
Overall Study	STARTED	Auto-Auto High Risk	48
Overall Study	STARTED	Auto-Allo High Risk	37
Overall Study	COMPLETED	Auto-Auto Standard Risk	178
Overall Study	COMPLETED	Auto-Allo Standard Risk	71
Overall Study	COMPLETED	Auto-Auto High Risk	14
Overall Study	COMPLETED	Auto-Allo High Risk	13
Overall Study	NOT COMPLETED	Auto-Auto Standard Risk	258
Overall Study	NOT COMPLETED	Auto-Allo Standard Risk	118

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

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	Thrombocytopenia	Blood and lymphatic system disorders	Auto-Auto Standard Risk	1	436	1
other	Thrombocytopenia	Blood and lymphatic system disorders	Auto-Allo Standard Risk	0	189	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Auto-Auto High Risk	0	48
other	Thrombocytopenia	Blood and lymphatic system disorders	Auto-Allo High Risk	0	37
other	Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Auto-Auto Standard Risk	0	436	0
other	Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Auto-Allo Standard Risk	1	189	1
other	Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Auto-Auto High Risk	0	48
other	Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Auto-Allo High Risk	0	37
serious	Thrombocytopenic purpura	Blood and lymphatic system disorders	Auto-Auto Standard Risk	0	436
serious	Thrombocytopenic purpura	Blood and lymphatic system disorders	Auto-Allo Standard Risk	0	189

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Auto-Auto Standard Risk
Total, all-cause mortality	Auto-Allo Standard Risk
Total, all-cause mortality	Auto-Auto High Risk
Total, all-cause mortality	Auto-Allo High Risk
Total, other adverse events	Auto-Auto Standard Risk	1	436
Total, other adverse events	Auto-Allo Standard Risk	1	189
Total, other adverse events	Auto-Auto High Risk	0	48
Total, other adverse events	Auto-Allo High Risk	0	37
Total, serious adverse events	Auto-Auto Standard Risk	15	436
Total, serious adverse events	Auto-Allo Standard Risk	10	189

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19029209	RESULT	PubMed
21962393	RESULT	PubMed
31756536	DERIVED	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.

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