Trial · NCT01083316

Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis

NCT01083316, Phase 2, Completed, Boston Medical Center; results first posted 2017-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis. Trials, record NCT01083316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01083316

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Trial

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

Title: Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis
NCT number: NCT01083316
Status: Completed
Phases: Phase 2
Enrollment: 35 participants, actual
Lead sponsor: Boston Medical Center
Conditions: Amyloidosis
Interventions: Bortezomib, Dexamethasone, Melphalan
First posted: 2010-03-09
Last updated: 2020-09-25
Results first posted: 2017-02-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Disease Response	One year	Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: \>50% Reduction in the difference in serum free light chains
Primary	Number of Participants Surviving at 100 Days Post Transplant	100 days
Primary	Number of Participants Proceeding to Transplant Following Induction	2 months
Secondary	Number of Participants Surviving at 5 Years	5 years

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Disease Response	One year		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Surviving at 100 Days Post Transplant	100 days		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Proceeding to Transplant Following Induction	2 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Surviving at 5 Years	5 years	number of patients that completed at least one cycle of induction therapy	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Number of Participants With Disease Response	Bortezomib and Dexamethasone	20	Participants
Number of Participants Surviving at 100 Days Post Transplant	Bortezomib and Dexamethasone	27	Participants
Number of Participants Proceeding to Transplant Following Induction	Bortezomib and Dexamethasone	30	Participants
Number of Participants Surviving at 5 Years	Bortezomib and Dexamethasone	29	Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Bortezomib and Dexamethasone	35
Overall Study	COMPLETED	Bortezomib and Dexamethasone	32
Overall Study	NOT COMPLETED	Bortezomib and Dexamethasone	3

Source ClinicalTrials.gov

Adverse events47

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	alkaline phosphatase elevated	Investigations	Bortezomib and Dexamethasone	4	35	4
other	drug rash	Blood and lymphatic system disorders	Bortezomib and Dexamethasone	3	35	3
other	tinnitus	Ear and labyrinth disorders	Bortezomib and Dexamethasone	2	35	2
other	nausea	Gastrointestinal disorders	Bortezomib and Dexamethasone	15	35	15
other	diarrhea	Gastrointestinal disorders	Bortezomib and Dexamethasone	14	35	14
other	adrenal insufficiency	Endocrine disorders	Bortezomib and Dexamethasone	4	35	4
other	constipation	Gastrointestinal disorders	Bortezomib and Dexamethasone	13	35	13
other	anorexia	Gastrointestinal disorders	Bortezomib and Dexamethasone	5	35	5
other	abdominal distension	Gastrointestinal disorders	Bortezomib and Dexamethasone	4	35	4
other	hypotension	Vascular disorders	Bortezomib and Dexamethasone	8	35	8

1 to 10 of 47Source ClinicalTrials.gov

See all 47 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bortezomib and Dexamethasone
Total, other adverse events	Bortezomib and Dexamethasone	35	35
Total, serious adverse events	Bortezomib and Dexamethasone	35	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01083316

GET https://conductscience.org/api/trials/v1/NCT01083316/events?page=2

API reference For AI assistants