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A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis (CATALYST)

Primary Purpose

Amyloidosis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Carfilzomib
Thalidomide
Dexamethasone
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis focused on measuring Amyloidosis, AL Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with the following characteristics are eligible for this study:

    1. Aged 18 years or greater
    2. Diagnosis of systemic AL amyloidosis with:

      • exclusion of genetic mutations associated with hereditary amyloidosis and immunohistochemical exclusion of AA and TTR amyloidosis as appropriate.
      • Amyloid related organ dysfunction or organ syndrome
    3. Measurable clonal disease
    4. Clonal relapse after previous chemotherapy or stem cell transplant OR refractory clonal disease to previous chemotherapy or stem cell transplant
    5. Capable of providing written, informed consent and willing to follow study protocol
    6. Life expectancy ≥ 6 months
    7. ECOG performance status of <3
    8. Platelet count ≥ 50x109/l)
    9. Neutrophil count ≥ 1x109/l)
    10. Haemoglobin ≥ 8g/dL
    11. Bilirubin <2 times or Alkaline phosphatase <4 times upper limit of normal.
    12. Female participants of child-bearing potential must have a negative pregnancy test prior to treatment and agree to use dual methods of contraception for the duration of the study and for 30 days following completion of study. Male participants must also agree to use a barrier method of contraception for the duration of the study and for 30 days following completion of study if sexually active with a female of child-bearing potential. Participants must comply with the Celgene pregnancy prevention programme for thalidomide

Exclusion Criteria:

  • Patients with the following characteristics are ineligible for this study:

    1. Overt symptomatic multiple myeloma
    2. Amyloidosis of unknown or non AL type
    3. Localised AL amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ)
    4. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome).
    5. Refractory to or progressive disease with an IMid and proteasome inhibitor combination
    6. Allogeneic stem cell transplantation
    7. Solid organ transplantation
    8. Severe peripheral or autonomic neuropathy causing significant functional impairment.
    9. eGFR <20ml/min
    10. Ejection fraction < 40% or NYHA class III or IV heart failure or uncontrolled hypertension
    11. Pulmonary Hypertension
    12. Advanced Mayo stage III disease as defined by hs-Troponin T>0.07 and NT-proBNP >700 pMol/L OR NT-proBNP >1000 pMol/L OR supine SBP <100 mm of Hg
    13. Myocardial infarction in the preceeding 6 months or unstable angina or conduction abnormalities uncontrolled by medication or devices
    14. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
    15. Pregnant, lactating or unwilling to use adequate contraception
    16. Systemic infection unless specific anti-infective therapy is employed.
    17. Known or suspected HIV infection
    18. Contraindication to any of the required concomitant drugs or supportive treatments. Any other clinically significant medical disease or condition or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent
    19. Previous experimental agents or approved anti-tumour treatment within 3 months before the date of registration
    20. Known allergies to the IMPs

Sites / Locations

  • Derriford Hospital
  • Royal Bournemouth General Hospital
  • Guy's Hospital
  • Manchester Royal Infirmary
  • Southampton General Hospital
  • Leicester Royal Infirmary
  • Norfolk and Norwich University Hospital
  • Royal Hallamshire Hospital
  • Freeman Hospital
  • Birmingham Queen Elizabeth Hospital
  • Birmingham Heartlands Hospital
  • St James' University Hospital
  • Bristol Haematology and Oncology Centre
  • The Beatson West of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KTD treatment

Arm Description

Participants in the escalation phase will receive carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be administered on Day 1, 8, and 15, but the level of carfilzomib delivered with depend on the cohort allocation. The dose of carfilzomib may be: Level -1 - 27mg/m2 Level 0 - 36mg/m2 Level 1 - 45mg/m2 Level 2 - 56mg/m2 Participants will receive up to six cycles of treatment. Following determination of the maximum tolerated dose and recommended dose, the trial will be opened to an expansion phase where participants will receive the RD of carfilzomib, along with thalidomide and dexamethasone, using the schedule outlined above.

Outcomes

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data
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.
Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.
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 Outcome Measures

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.
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
Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.
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.
Time to Amyloidotic Organ Response Based on Reported Data.
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.
Number of Deaths at 6 Months Based on Reported Data.
The number of deaths at 6 months will be assessed and reported based on reported data.
Number of Patients Progression-free at 6 Months Based on Reported Data.
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
Maximum Response Determined by Paraprotein and Free Light Chain Assessment.
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).
Time to Maximum Response Based on Reported Data.
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.
Number of Patients Withdrawing From Treatment Based on Reported Data.
The number of patients withdrawing from treatment will be assessed based on reported data.
Number of Patients Experiencing Dose Delays Based on Reported Data.
The number of patients experiencing dose delays will be assessed based on reported data.
Compliance Profile of KTD Based on Reported Chemotherapy Compliance Data.
The compliant profile of participants to KTD will be assessed by determining the number of missed doses from recorded data. Participants will be regarded as compliant if participants have missed no more than 14 days of thalidomide, 2 days of dexamethasone, and 1 dose of carfilzomib per cycle. Compliance will be reported in terms of the number of participants who were compliant.

Full Information

First Posted
August 27, 2015
Last Updated
March 18, 2021
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02545907
Brief Title
A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
Acronym
CATALYST
Official Title
A Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the safety and efficacy of carfilzomib used in combination with thalidomide and dexamethasone in patients with relapsed AL amyloidosis. The trial begins with a dose escalation phase, in which the maximum tolerated and recommended dose will be determined. The trial will then open into an expansion phase in which the combination efficacy is assessed.
Detailed Description
Amyloidosis is a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function. The treatment of systemic AL amyloidosis has evolved to a risk adapted approach based on the end organ damage, particularly cardiac involvement, and the functional status of the patient. Intensive therapies like high dose melphalan followed by an autologous stem cell transplant are considered for patients with limited organ involvement, younger age and excellent functional status. The majority of patients with AL amyloidosis, however, will not be candidates for ASCT and are generally treated with combination chemotherapy. This therapy may include bortezomib, a proteasome inhibitor which is particularly effective in AL amyloidosis but which may have a severe side-effect profile. Carfilzomib is specific for the chymotrypsin-like active site of the 20S proteasome, is structurally and mechanistically distinct from bortezomib, and has demonstrated less reactivity against non-proteasomal proteases when compared to bortezomib. It also appears to be better tolerated. However, information regarding the use of carfilzomib in the treatment of AL amyloidosis is limited. In the dose escalation phase of this study, a minimum of 6 (3 at dose level 0 and 3 at dose level -1)and a maximum of 18 (6 at dose level 0, 1, and 2) patients will recruited in a 3+3 design with cohorts of between 3 and 6 patients, in order to determine maximum tolerated dose and recommended dose. At the recommended dose level identified, a further 20 (minimum) patients will be recruited to further assess safety and toxicities at the RD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis
Keywords
Amyloidosis, AL Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KTD treatment
Arm Type
Experimental
Arm Description
Participants in the escalation phase will receive carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be administered on Day 1, 8, and 15, but the level of carfilzomib delivered with depend on the cohort allocation. The dose of carfilzomib may be: Level -1 - 27mg/m2 Level 0 - 36mg/m2 Level 1 - 45mg/m2 Level 2 - 56mg/m2 Participants will receive up to six cycles of treatment. Following determination of the maximum tolerated dose and recommended dose, the trial will be opened to an expansion phase where participants will receive the RD of carfilzomib, along with thalidomide and dexamethasone, using the schedule outlined above.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
Kyprolis
Intervention Description
Lyophilized carfilzomib for injection reconstituted with water to a final concentration of 2 mg/mL.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalidomide Celgene
Intervention Description
50mg capsule.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
2mg tablet.
Primary Outcome Measure Information:
Title
Number of Participants With Dose-Limiting Toxicities as Assessed by Reported Data
Description
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.
Time Frame
After 1 cycle of treatment; to be completed within 1 year.
Title
Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.
Description
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.
Time Frame
Between informed consent provided and 30 days post last trial treatment administration, up to 7 months
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Within 3 months, at 3 months, within 6 months and at 6 months
Title
Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.
Description
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.
Time Frame
Within 3 months and 6 months
Title
Time to Amyloidotic Organ Response Based on Reported Data.
Description
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.
Time Frame
Within 6 months
Title
Number of Deaths at 6 Months Based on Reported Data.
Description
The number of deaths at 6 months will be assessed and reported based on reported data.
Time Frame
6 months
Title
Number of Patients Progression-free at 6 Months Based on Reported Data.
Description
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
Time Frame
6 months
Title
Maximum Response Determined by Paraprotein and Free Light Chain Assessment.
Description
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).
Time Frame
Within 6 months
Title
Time to Maximum Response Based on Reported Data.
Description
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.
Time Frame
Within 6 months
Title
Number of Patients Withdrawing From Treatment Based on Reported Data.
Description
The number of patients withdrawing from treatment will be assessed based on reported data.
Time Frame
Within 6 months
Title
Number of Patients Experiencing Dose Delays Based on Reported Data.
Description
The number of patients experiencing dose delays will be assessed based on reported data.
Time Frame
Within 6 months
Title
Compliance Profile of KTD Based on Reported Chemotherapy Compliance Data.
Description
The compliant profile of participants to KTD will be assessed by determining the number of missed doses from recorded data. Participants will be regarded as compliant if participants have missed no more than 14 days of thalidomide, 2 days of dexamethasone, and 1 dose of carfilzomib per cycle. Compliance will be reported in terms of the number of participants who were compliant.
Time Frame
Within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with the following characteristics are eligible for this study: Aged 18 years or greater Diagnosis of systemic AL amyloidosis with: exclusion of genetic mutations associated with hereditary amyloidosis and immunohistochemical exclusion of AA and TTR amyloidosis as appropriate. Amyloid related organ dysfunction or organ syndrome Measurable clonal disease Clonal relapse after previous chemotherapy or stem cell transplant OR refractory clonal disease to previous chemotherapy or stem cell transplant Capable of providing written, informed consent and willing to follow study protocol Life expectancy ≥ 6 months ECOG performance status of <3 Platelet count ≥ 50x109/l) Neutrophil count ≥ 1x109/l) Haemoglobin ≥ 8g/dL Bilirubin <2 times or Alkaline phosphatase <4 times upper limit of normal. Female participants of child-bearing potential must have a negative pregnancy test prior to treatment and agree to use dual methods of contraception for the duration of the study and for 30 days following completion of study. Male participants must also agree to use a barrier method of contraception for the duration of the study and for 30 days following completion of study if sexually active with a female of child-bearing potential. Participants must comply with the Celgene pregnancy prevention programme for thalidomide Exclusion Criteria: Patients with the following characteristics are ineligible for this study: Overt symptomatic multiple myeloma Amyloidosis of unknown or non AL type Localised AL amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ) Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome). Refractory to or progressive disease with an IMid and proteasome inhibitor combination Allogeneic stem cell transplantation Solid organ transplantation Severe peripheral or autonomic neuropathy causing significant functional impairment. eGFR <20ml/min Ejection fraction < 40% or NYHA class III or IV heart failure or uncontrolled hypertension Pulmonary Hypertension Advanced Mayo stage III disease as defined by hs-Troponin T>0.07 and NT-proBNP >700 pMol/L OR NT-proBNP >1000 pMol/L OR supine SBP <100 mm of Hg Myocardial infarction in the preceeding 6 months or unstable angina or conduction abnormalities uncontrolled by medication or devices Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas Pregnant, lactating or unwilling to use adequate contraception Systemic infection unless specific anti-infective therapy is employed. Known or suspected HIV infection Contraindication to any of the required concomitant drugs or supportive treatments. Any other clinically significant medical disease or condition or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent Previous experimental agents or approved anti-tumour treatment within 3 months before the date of registration Known allergies to the IMPs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashutosh Wechalekar, Dr
Organizational Affiliation
University College London, National Amyloidosis Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Bournemouth General Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle-upon-Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Birmingham Queen Elizabeth Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
St James' University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis

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