Trial · NCT01383759
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
NCT01383759, Not applicable, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2020-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis. Trials, record NCT01383759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01383759
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
- NCT number
- NCT01383759
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 20 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Light Chain Deposition Disease (LCDD or MIDD), Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD), Monoclonal Immunoglobulin Deposition Disease (MIDD), Amyloidosis
- Interventions
- Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone
- First posted
- 2011-06-28
- Last updated
- 2020-04-07
- Results first posted
- 2020-03-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Progression Free Survival at 12 Months | 12 months | of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Primary | Participants Evaluated for Toxicity | 2 years | Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. |
| Secondary | To Estimate the Hematologic Response Rate | 2 years | \[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach. |
| Secondary | Organ Response - Cardiac Involvement at 12 Months | 12 months | 12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Secondary | Progression Free Survival at 24 Months | 24 months | following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Secondary | Organ Response - Cardiac Involvement at 24 Months | 24 months | 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Secondary | Organ Response - Renal Involvement at 12 Months | 12 months | 12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
| Secondary | Organ Response - Renal Involvement at 24 Months | 24 months | 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. |
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 | Percentage of Participants Experiencing Progression Free Survival at 12 Months | 12 months | Data were not collected for MIDD group. | percentage of patients | NUMBER |
| PRIMARY | Participants Evaluated for Toxicity | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Estimate the Hematologic Response Rate | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Organ Response - Cardiac Involvement at 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival at 24 Months | 24 months | percentage of patients | NUMBER | |
| SECONDARY | Organ Response - Cardiac Involvement at 24 Months | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Organ Response - Renal Involvement at 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Organ Response - Renal Involvement at 24 Months | 24 months | 1 participants died at the previous 12 month follow up point | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Progression Free Survival at 12 Months | Amyloidosis | 84 | 95% Confidence Interval 69 to 99 | percentage of patients | |
| Participants Evaluated for Toxicity | Amyloidosis | 19 | Participants | ||
| Participants Evaluated for Toxicity | Monoclonal Ig DepositionDisease (MIDD) | 1 | Participants | ||
| To Estimate the Hematologic Response Rate | Amyloidosis | Complete Response (CR) | 7 | Participants | |
| To Estimate the Hematologic Response Rate | Monoclonal Ig DepositionDisease (MIDD) | Complete Response (CR) | 0 | Participants | |
| To Estimate the Hematologic Response Rate | Amyloidosis | Partial Response (PR) | 4 | Participants | |
| To Estimate the Hematologic Response Rate | Monoclonal Ig DepositionDisease (MIDD) | Partial Response (PR) | 0 | Participants | |
| To Estimate the Hematologic Response Rate | Amyloidosis | Progression of Disease (POD) | 1 | Participants | |
| To Estimate the Hematologic Response Rate | Monoclonal Ig DepositionDisease (MIDD) | Progression of Disease (POD) | 0 | Participants | |
| To Estimate the Hematologic Response Rate | Amyloidosis | Stable Disease (SD) | 1 | Participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amyloidosis | 19 | |
| Overall Study | STARTED | Monoclonal Ig DepositionDisease (MIDD) | 1 | |
| Overall Study | COMPLETED | Amyloidosis | 19 | |
| Overall Study | COMPLETED | Monoclonal Ig DepositionDisease (MIDD) | 1 | |
| Overall Study | NOT COMPLETED | Amyloidosis | 0 | |
| Overall Study | NOT COMPLETED | Monoclonal Ig DepositionDisease (MIDD) | 0 |
Source ClinicalTrials.gov
Adverse events252
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 | Abdominal pain | Gastrointestinal disorders | Amyloidosis | 1 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | Monoclonal Ig DepositionDisease (MIDD) | 0 | 1 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Amyloidosis | 7 | 19 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Monoclonal Ig DepositionDisease (MIDD) | 0 | 1 | |
| other | Alanine aminotransferase increased | Investigations | Amyloidosis | 13 | 19 | |
| other | Alanine aminotransferase increased | Investigations | Monoclonal Ig DepositionDisease (MIDD) | 1 | 1 | |
| other | Alkaline phosphatase increased | Investigations | Amyloidosis | 17 | 19 | |
| other | Alkaline phosphatase increased | Investigations | Monoclonal Ig DepositionDisease (MIDD) | 1 | 1 | |
| other | Allergic reaction | Immune system disorders | Amyloidosis | 1 | 19 | |
| other | Allergic reaction | Immune system disorders | Monoclonal Ig DepositionDisease (MIDD) | 0 | 1 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amyloidosis | 7 | 19 |
| Total, all-cause mortality | Monoclonal Ig DepositionDisease (MIDD) | 0 | 1 |
| Total, other adverse events | Amyloidosis | 19 | 19 |
| Total, other adverse events | Monoclonal Ig DepositionDisease (MIDD) | 1 | 1 |
| Total, serious adverse events | Amyloidosis | 17 | 19 |
| Total, serious adverse events | Monoclonal Ig DepositionDisease (MIDD) | 1 | 1 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amyloidosis vs Monoclonal Ig DepositionDisease (MIDD): Participants Evaluated for Toxicity | Trial comparisons |
| Amyloidosis vs Monoclonal Ig DepositionDisease (MIDD): deaths from any cause | Trial comparisons |
| Amyloidosis vs Monoclonal Ig DepositionDisease (MIDD): serious adverse events | Trial comparisons |
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.
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/NCT01383759
GET https://conductscience.org/api/trials/v1/NCT01383759/results?page=2