Trial · NCT01570387
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
NCT01570387, Phase 1, Phase 2, Completed, Boston Medical Center; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis. Trials, record NCT01570387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01570387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
- NCT number
- NCT01570387
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- AL Amyloidosis
- Interventions
- Pomalidomide, Dexamethasone
- First posted
- 2012-04-04
- Last updated
- 2020-09-22
- Results first posted
- 2019-12-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose | one month | Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis |
| Primary | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose | One month | Number of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2. |
| Primary | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose | One month | Number of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort |
| Secondary | Response to the Maximal Tolerated Dose | one year | Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses) |
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 | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose | one month | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose | One month | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose | One month | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response to the Maximal Tolerated Dose | one year | Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose | Pom Plus Dex | 0 | Participants | ||
| Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose | Pom Plus Dex | 0 | Participants | ||
| Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose | Pom Plus Dex | 1 | Participants | ||
| Response to the Maximal Tolerated Dose | Pom Plus Dex | 10 | Participants |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Phase I - Cohort 1 (Pomalidomide 2mg) | 6 | |
| Overall Study | STARTED | Experimental: Phase I - Cohort 2 (Pomalidomide 3mg) | 3 | |
| Overall Study | STARTED | Experimental: Phase I - Cohort 3 (Pomalidomide 4mg) | 6 | |
| Overall Study | STARTED | Experimental: Phase II Expansion- Maximum Tolerated Dose | 12 | |
| Overall Study | Dose Limiting Toxicity | Experimental: Phase I - Cohort 1 (Pomalidomide 2mg) | 0 | |
| Overall Study | Dose Limiting Toxicity | Experimental: Phase I - Cohort 2 (Pomalidomide 3mg) | 0 | |
| Overall Study | Dose Limiting Toxicity | Experimental: Phase I - Cohort 3 (Pomalidomide 4mg) | 6 | |
| Overall Study | Dose Limiting Toxicity | Experimental: Phase II Expansion- Maximum Tolerated Dose | 12 | |
| Overall Study | Response to Maximal Tolerated Dose | Experimental: Phase I - Cohort 1 (Pomalidomide 2mg) | 0 | |
| Overall Study | Response to Maximal Tolerated Dose | Experimental: Phase I - Cohort 2 (Pomalidomide 3mg) | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events316
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 | White blood cell count decreased | Investigations | Phase I - Cohort 1 (Pomalidomide 2mg) | 3 | 6 | 3 |
| other | White blood cell count decreased | Investigations | Phase I - Cohort 2 (Pomalidomide 3mg) | 0 | 3 | 0 |
| other | White blood cell count decreased | Investigations | Phase I - Cohort 3 (Pomalidomide 4mg) | 1 | 6 | 4 |
| other | White blood cell count decreased | Investigations | Phase II Expansion- Maximum Tolerated Dose | 10 | 12 | 15 |
| other | wheezing | Respiratory, thoracic and mediastinal disorders | Phase I - Cohort 1 (Pomalidomide 2mg) | 0 | 6 | 0 |
| other | wheezing | Respiratory, thoracic and mediastinal disorders | Phase I - Cohort 2 (Pomalidomide 3mg) | 1 | 3 | 1 |
| other | wheezing | Respiratory, thoracic and mediastinal disorders | Phase I - Cohort 3 (Pomalidomide 4mg) | 2 | 6 | 2 |
| other | wheezing | Respiratory, thoracic and mediastinal disorders | Phase II Expansion- Maximum Tolerated Dose | 0 | 12 | 0 |
| other | weakness | General disorders | Phase I - Cohort 1 (Pomalidomide 2mg) | 3 | 6 | 3 |
| other | weakness | General disorders | Phase I - Cohort 2 (Pomalidomide 3mg) | 1 | 3 | 1 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Cohort 1 (Pomalidomide 2mg) | 1 | 6 |
| Total, all-cause mortality | Phase I - Cohort 2 (Pomalidomide 3mg) | 0 | 3 |
| Total, all-cause mortality | Phase I - Cohort 3 (Pomalidomide 4mg) | 0 | 6 |
| Total, all-cause mortality | Phase II Expansion- Maximum Tolerated Dose | 1 | 12 |
| Total, other adverse events | Phase I - Cohort 1 (Pomalidomide 2mg) | 6 | 6 |
| Total, other adverse events | Phase I - Cohort 2 (Pomalidomide 3mg) | 3 | 3 |
| Total, other adverse events | Phase I - Cohort 3 (Pomalidomide 4mg) | 6 | 6 |
| Total, other adverse events | Phase II Expansion- Maximum Tolerated Dose | 12 | 12 |
| Total, serious adverse events | Phase I - Cohort 1 (Pomalidomide 2mg) | 2 | 6 |
| Total, serious adverse events | Phase I - Cohort 2 (Pomalidomide 3mg) | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27381904 | 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.
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/NCT01570387
GET https://conductscience.org/api/trials/v1/NCT01570387/events?page=2