Trial · NCT02545907
A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
NCT02545907, Phase 1, Phase 2, Completed, University College, London; results first posted 2021-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis. Trials, record NCT02545907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02545907
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
- NCT number
- NCT02545907
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University College, London
- Conditions
- Amyloidosis
- Interventions
- Carfilzomib, Thalidomide, Dexamethasone
- First posted
- 2015-09-10
- Last updated
- 2021-04-15
- Results first posted
- 2021-04-15
- Limitations and caveats
- The trial closed to recruitment following the dose escalation stage without opening the expansion phase due to slow recruitment.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data | After 1 cycle of treatment; to be completed within 1 year. | Dose-Limiting Toxicities (Dose escalation phase), between the time of receiving the first registered dose of carfilzomib in cycle 1 and day 1 cycle 2, in order to establish the Maximum Tolerated Dose (MTD) of carfilzomib in combination with thalidomide and dexamethasone, will be assessed based on reported data. The number of reported dose limiting toxicities will be reported. |
| Primary | Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. | Between informed consent provided and 30 days post last trial treatment administration, up to 7 months | The percentage of patients treated who experience any grade 3 or 4 toxicity as assessed by CTCAE v4.0 throughout all treatment cycles will be assessed based on reported data. |
| Secondary | Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Within 3 months, at 3 months, within 6 months and at 6 months | Participant clonal response rate within 3 months, at 3 months, within 6 months and at 6 months will be assessed. The percentage of participants who achieve at least a partial response will be reported. Clonal response is defined as: CR: Negative immunofixation of serum and urine (serum alone in anuric patients) AND normal FLC concentration and kappa/lambda FLC ratio (FLC ratio alone in renal failure) AND ≤5% plasma cells in bone marrow without clonality by immunohistochemistry or immunofluorescencea VGPR: \>90% reduction in serum paraprotein or abnormal component of FLC or dFLC over the starting value or dFLC \<40mg/L PR: ≥50% decrease in aberrant FLC concentration or dFLC (or ≥50% decrease in dFLC if renal failure) or serum paraprotein but not fulfilling criteria for CR or VGPR MR: \>25% but \<50% decrease in aberrant FLC or dFLC or paraprotein NR: Not meeting FLC criteria for CR, PR or MR |
| Secondary | Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment. | Within 3 months and 6 months | Amyloidotic organ response rate is assessed using the following criteria: Heart - Interventricular septal thickness decreased by 2 mm or 10% improvement in ejection fraction or a 30% and 35 pMol/L reduction in NT-ProBNP (only applicable if there is no change or \<25% improvement in renal function) or significant improvement in lateral wall TDI S wave and E/E' ratio Kidney - 50% decrease (at least 0.5 g/day) in 24-hr urinary protein loss (urine protein must be\>0.5 g/day pretreatment) without fall in creatinine clearance of ≥25% from baseline Liver - 50% decrease in abnormal alkaline phosphatase value or a decrease in liver size radiographically by at least 2 cm Nerve - Improvement in electromyogram nerve conduction velocity Soft tissue - Definite clinical and/or radiographic improvement with associated functional improvement in affected tissue. The percentage of patients who achieve organ response within 3 and 6 months of trial registration will be reported. |
| Secondary | Time to Amyloidotic Organ Response Based on Reported Data. | Within 6 months | The time to amyloidotic organ response (as outlined above) will be assessed based on reported data. The number of months this takes will be reported. |
| Secondary | Number of Deaths at 6 Months Based on Reported Data. | 6 months | The number of deaths at 6 months will be assessed and reported based on reported data. |
| Secondary | Number of Patients Progression-free at 6 Months Based on Reported Data. | 6 months | The number of patients who are progression-free at 6 months will be assessed based on reported data. Patients who are progression-free will have not had an haematological relapse or organ progression. Haematological relapse is defined as: From CR: Increase in the aberrant serum free light chain concentration to outside the normal range and by a factor of ≥2 from that at the time of CR or re-appearance of the original paraprotein From PR or VGPR: Increase in the aberrant free light chain concentration by a factor of ≥2 from that at the time of PR (≥50% change in ratio away from normal in patients with renal failure) or doubling of the serum paraprotein level (if starting \>5g/L) or doubling and increase of serum paraprotein to \>5g/L (if starting \<5g/L) Organ progression is defined, by organ, as: Heart: Interventricular septal thickness increased by \>2 mm compared with baseline or 20% decline in ejection fraction Kidney: 50% increase (at least 1 g/day) in 24-hr urinary |
| Secondary | Maximum Response Determined by Paraprotein and Free Light Chain Assessment. | Within 6 months | The maximum response to therapy will be determined by assessing the best reported response for each participant. Maximum response will be determined based on free light chain and paraprotein assessments by the National Amyloidosis Centre. The data will be reported using the response rates observed (complete, very good partial, partial, no response). |
| Secondary | Time to Maximum Response Based on Reported Data. | Within 6 months | The time to maximum response to treatment will be assessed by determining the time required for each participant to achieve maximum response (defined above), and will be presented on Kaplan-Meier curves. The number of months taken to achieve this maximum response will be reported. Time to maximum response was analysed overall only, and not by arm due the small sample size. |
| Secondary | Number of Patients Withdrawing From Treatment Based on Reported Data. | Within 6 months | The number of patients withdrawing from treatment will be assessed based on reported data. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Dose-Limiting Toxicities as Assessed by Reported Data | After 1 cycle of treatment; to be completed within 1 year. | Evaluable set- patient who received at least one cycle of the study treatment. KTD Patients who do not receive one complete cycle due to experiencing a DLT will be included in the analysis; patients who do not receive at least one complete cycle for reasons other than toxicity, without experiencing a DLT, and who miss a dose of Carfilzomib, more than 14 doses Thalidomide or 2 doses of Dexamethasone in the first cycle, will be replaced. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. | Between informed consent provided and 30 days post last trial treatment administration, up to 7 months | All patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Within 3 months, at 3 months, within 6 months and at 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment. | Within 3 months and 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Amyloidotic Organ Response Based on Reported Data. | Within 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Deaths at 6 Months Based on Reported Data. | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Progression-free at 6 Months Based on Reported Data. | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maximum Response Determined by Paraprotein and Free Light Chain Assessment. | Within 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Maximum Response Based on Reported Data. | Within 6 months | months | MEDIAN | |
| SECONDARY | Number of Patients Withdrawing From Treatment Based on Reported Data. | Within 6 months | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data | Dose Level 0 | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data | Dose Level 1 | 1 | Participants | ||
| Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. | Dose Level 0- Safety Population | 2 | Participants | ||
| Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. | Dose Level 1- Safety Population | 3 | Participants | ||
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 0- Safety Population | Within 3 cycles | 1 | Participants | |
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 1- Safety Population | Within 3 cycles | 5 | Participants | |
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 0- Safety Population | At the end of cycle 3 | 1 | Participants | |
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 1- Safety Population | At the end of cycle 3 | 5 | Participants | |
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 0- Safety Population | Within 6 cycles | 2 | Participants | |
| Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment. | Dose Level 1- Safety Population | Within 6 cycles | 5 | Participants |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Period 1- Dose Level 0 - 36mg/m^2 | 3 | |
| Overall Study | STARTED | Period 2 - Dose Level 1 - 45mg/m^2 | 3 | |
| Overall Study | STARTED | Period 3 - Dose Level 1 - 45mg/m^2 | 4 | |
| Overall Study | COMPLETED | Period 1- Dose Level 0 - 36mg/m^2 | 3 | |
| Overall Study | COMPLETED | Period 2 - Dose Level 1 - 45mg/m^2 | 3 | |
| Overall Study | COMPLETED | Period 3 - Dose Level 1 - 45mg/m^2 | 4 | |
| Overall Study | NOT COMPLETED | Period 1- Dose Level 0 - 36mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Period 2 - Dose Level 1 - 45mg/m^2 | 0 | |
| Overall Study | NOT COMPLETED | Period 3 - Dose Level 1 - 45mg/m^2 | 0 |
Source ClinicalTrials.gov
Adverse events110
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 | Hypertension | Vascular disorders | Dose Level 0 - Safety Population | 2 | 3 | 2 |
| other | Hypertension | Vascular disorders | Dose Level 1 - Safety Population | 0 | 7 | 0 |
| other | Hypotension | Vascular disorders | Dose Level 0 - Safety Population | 0 | 3 | 0 |
| other | Hypotension | Vascular disorders | Dose Level 1 - Safety Population | 1 | 7 | 1 |
| other | Social circumstances - Other, specify | Social circumstances | Dose Level 0 - Safety Population | 0 | 3 | 0 |
| other | Social circumstances - Other, specify | Social circumstances | Dose Level 1 - Safety Population | 1 | 7 | 1 |
| other | Edema face | General disorders | Dose Level 0 - Safety Population | 0 | 3 | 0 |
| other | Edema face | General disorders | Dose Level 1 - Safety Population | 1 | 7 | 1 |
| other | Edema limbs | General disorders | Dose Level 0 - Safety Population | 2 | 3 | 2 |
| other | Edema limbs | General disorders | Dose Level 1 - Safety Population | 5 | 7 | 5 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 0 - Safety Population | 0 | 3 |
| Total, all-cause mortality | Dose Level 1 - Safety Population | 0 | 7 |
| Total, other adverse events | Dose Level 0 - Safety Population | 3 | 3 |
| Total, other adverse events | Dose Level 1 - Safety Population | 7 | 7 |
| Total, serious adverse events | Dose Level 0 - Safety Population | 1 | 3 |
| Total, serious adverse events | Dose Level 1 - Safety Population | 2 | 7 |
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Time to Amyloidotic Organ Response Based on Reported Data. | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Patients Progression-free at 6 Months Based on Reported Data. | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Patients Experiencing Dose Delays Based on Reported Data. | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Compliance Profile of KTD Based on Reported Chemotherapy Compliance Data. | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Patients Withdrawing From Treatment Based on Reported Data. | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0. | Trial comparisons |
| Dose Level 0 - Safety Population vs Dose Level 1 - Safety Population: deaths from any cause | Trial comparisons |
| Dose Level 0- Safety Population vs Dose Level 1- Safety Population: Number of Deaths at 6 Months Based on Reported Data. | Trial comparisons |
| Dose Level 0 vs Dose Level 1: Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data | Trial comparisons |
| Dose Level 0 - Safety Population vs Dose Level 1 - Safety Population: 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/NCT02545907
GET https://conductscience.org/api/trials/v1/NCT02545907/results?page=2