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Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (ADMYRE)

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Plitidepsin
Dexamethasone
Sponsored by
PharmaMar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Multiple Myeloma, Aplidin, plitidepsin, dexamethasone

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
  • Life expectancy ≥ 3 months.
  • Patients previously diagnosed with multiple myeloma
  • Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.
  • Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
  • Women must have a negative serum pregnancy test
  • Voluntarily signed and dated written informed consent

Exclusion Criteria:

  • Concomitant diseases/conditions
  • Women who are pregnant or breast feeding.
  • Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
  • Known hypersensitivity to any involved study drug or any of its formulation components

Sites / Locations

  • 1107
  • 1103
  • 1105
  • 1102
  • 1104
  • 108
  • 102
  • 101
  • 105
  • 106
  • 104
  • 109
  • 202
  • 204
  • 203
  • 201
  • 205
  • 208
  • 304
  • 301
  • 303
  • 302
  • 502
  • 503
  • 501
  • 601
  • 602
  • 606
  • 604
  • 709
  • 705
  • 706
  • 707
  • 708
  • 703
  • 702
  • 704
  • 1301
  • 1303
  • 1302
  • 1401
  • 806
  • 801
  • 805
  • 803
  • 804
  • 802
  • 1502
  • 1501
  • 1507
  • 1506
  • 1505
  • 1508
  • 1503
  • 1504
  • 1509
  • 901
  • 902
  • 1601
  • 1602
  • 1704
  • 1703
  • 1802
  • 1801
  • 2001
  • 1201
  • 1203
  • 1209
  • 1207
  • 1210
  • 1206
  • 1204
  • 1208
  • 1202
  • 1205
  • 1901
  • 1902
  • 1903
  • 1003
  • 1004
  • 1001
  • 1005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plitidepsin+Dexamethasone

Dexamethasone

Arm Description

plitidepsin + dexamethasone combination

dexamethasone single agent

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Outcome Measures

Progression-free Survival (Investigator Assessment)
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Overall Survival
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Percentage of Participants With Overall Survival at 12 Months
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Percentage of Participants With Overall Survival at 24 Months
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Duration of Response (Independent Review Committee)
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Duration of Response (Investigator Assessment)
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Best Overall Response (Independent Review Committee)
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Overall Response Rate (Independent Review Committee)
Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Overall Response Rate (Independent Review Committee) Excluding MR
Includes sCR, CR, VGPR and PR (excludes MR). Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Best Overall Response (Investigator Assessment)
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Overall Response Rate (Investigator Assessment)
Includes sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Overall Response Rate (Investigator Assessment) Excluding MR
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas

Full Information

First Posted
March 31, 2010
Last Updated
October 21, 2020
Sponsor
PharmaMar
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1. Study Identification

Unique Protocol Identification Number
NCT01102426
Brief Title
Aplidin - Dexamethasone in Relapsed/Refractory Myeloma
Acronym
ADMYRE
Official Title
Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaMar

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Detailed Description
Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR), overall survival (OS) and to rule out any effect of plitidepsin on the duration of the QT/QTc interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
Multiple Myeloma, Aplidin, plitidepsin, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plitidepsin+Dexamethasone
Arm Type
Experimental
Arm Description
plitidepsin + dexamethasone combination
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
dexamethasone single agent
Intervention Type
Drug
Intervention Name(s)
Plitidepsin
Other Intervention Name(s)
APLIDIN (plitidepsin)
Intervention Description
plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DXN
Intervention Description
4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
Description
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Title
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
Description
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (Investigator Assessment)
Description
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Title
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
Description
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Title
Overall Survival
Description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Time Frame
From randomization to the death due to any cause,assessed up to 5 years
Title
Percentage of Participants With Overall Survival at 12 Months
Description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Time Frame
From randomization to the death due to any cause,assessed up to 12 months
Title
Percentage of Participants With Overall Survival at 24 Months
Description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Time Frame
From randomization to the death due to any cause,assessed up to 24 months
Title
Duration of Response (Independent Review Committee)
Description
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
Description
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Title
Duration of Response (Investigator Assessment)
Description
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
Description
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months
Title
Best Overall Response (Independent Review Committee)
Description
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Overall Response Rate (Independent Review Committee)
Description
Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Overall Response Rate (Independent Review Committee) Excluding MR
Description
Includes sCR, CR, VGPR and PR (excludes MR). Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Best Overall Response (Investigator Assessment)
Description
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium >11.5 mg/dL; NE, not evaluable
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Overall Response Rate (Investigator Assessment)
Description
Includes sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
Title
Overall Response Rate (Investigator Assessment) Excluding MR
Description
Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or >90% reduction in serum M-protein and urine M-protein <100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to <200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 Life expectancy ≥ 3 months. Patients previously diagnosed with multiple myeloma Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen. Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available) Women must have a negative serum pregnancy test Voluntarily signed and dated written informed consent Exclusion Criteria: Concomitant diseases/conditions Women who are pregnant or breast feeding. Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM Known hypersensitivity to any involved study drug or any of its formulation components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Óscar F. Ballester, M.D.
Organizational Affiliation
Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rubén Niesvizky, M.D.
Organizational Affiliation
NY Presbyterian Hosp. - Cornell University - NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
1107
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
1103
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1105
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1102
City
New York
State/Province
New York
Country
United States
Facility Name
1104
City
Canton
State/Province
Ohio
Country
United States
Facility Name
108
City
Adelaide
Country
Australia
Facility Name
102
City
Canberra
Country
Australia
Facility Name
101
City
Geelong
Country
Australia
Facility Name
105
City
Parkville
Country
Australia
Facility Name
106
City
Perth
Country
Australia
Facility Name
104
City
South Brisbane
Country
Australia
Facility Name
109
City
Woodville
Country
Australia
Facility Name
202
City
Graz
Country
Austria
Facility Name
204
City
Innsbruck
Country
Austria
Facility Name
203
City
Salzburg
Country
Austria
Facility Name
201
City
Wien
Country
Austria
Facility Name
205
City
Wien
Country
Austria
Facility Name
208
City
Wien
Country
Austria
Facility Name
304
City
Brugge
Country
Belgium
Facility Name
301
City
Brussels
Country
Belgium
Facility Name
303
City
Brussels
Country
Belgium
Facility Name
302
City
Gent
Country
Belgium
Facility Name
502
City
Brno
Country
Czechia
Facility Name
503
City
Hradec Kralove
Country
Czechia
Facility Name
501
City
Praha
Country
Czechia
Facility Name
601
City
Lille
Country
France
Facility Name
602
City
Nantes
Country
France
Facility Name
606
City
Rouen
Country
France
Facility Name
604
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
709
City
Düsseldorf
Country
Germany
Facility Name
705
City
Essen
Country
Germany
Facility Name
706
City
Frankfurt
Country
Germany
Facility Name
707
City
Frankfurt
Country
Germany
Facility Name
708
City
Freiburg
Country
Germany
Facility Name
703
City
Heidelberg
Country
Germany
Facility Name
702
City
Munchen
Country
Germany
Facility Name
704
City
Würzburg
Country
Germany
Facility Name
1301
City
Athens
Country
Greece
Facility Name
1303
City
Patras
Country
Greece
Facility Name
1302
City
Thessaloniki
Country
Greece
Facility Name
1401
City
Dublin
Country
Ireland
Facility Name
806
City
Bari
Country
Italy
Facility Name
801
City
Genova
Country
Italy
Facility Name
805
City
Reggio Emilia
Country
Italy
Facility Name
803
City
Rozzano
Country
Italy
Facility Name
804
City
San Giovanni Rotondo
Country
Italy
Facility Name
802
City
Torino
Country
Italy
Facility Name
1502
City
Anyang
Country
Korea, Republic of
Facility Name
1501
City
Daejeon
Country
Korea, Republic of
Facility Name
1507
City
Hwasun
Country
Korea, Republic of
Facility Name
1506
City
Incheon
Country
Korea, Republic of
Facility Name
1505
City
Jeonju
Country
Korea, Republic of
Facility Name
1508
City
Seongnam
Country
Korea, Republic of
Facility Name
1503
City
Seoul
Country
Korea, Republic of
Facility Name
1504
City
Seoul
Country
Korea, Republic of
Facility Name
1509
City
Seoul
Country
Korea, Republic of
Facility Name
901
City
Rotterdam
Country
Netherlands
Facility Name
902
City
Rotterdam
Country
Netherlands
Facility Name
1601
City
Christchurch
Country
New Zealand
Facility Name
1602
City
Takapuna
Country
New Zealand
Facility Name
1704
City
Opole
Country
Poland
Facility Name
1703
City
Warszawa
Country
Poland
Facility Name
1802
City
Braga
Country
Portugal
Facility Name
1801
City
Porto
Country
Portugal
Facility Name
2001
City
San Juan
Country
Puerto Rico
Facility Name
1201
City
Barcelona
Country
Spain
Facility Name
1203
City
Barcelona
Country
Spain
Facility Name
1209
City
Barcelona
Country
Spain
Facility Name
1207
City
Madrid
Country
Spain
Facility Name
1210
City
Madrid
Country
Spain
Facility Name
1206
City
Murcia
Country
Spain
Facility Name
1204
City
Palma de Mallorca
Country
Spain
Facility Name
1208
City
Salamanca
Country
Spain
Facility Name
1202
City
San Sebastián
Country
Spain
Facility Name
1205
City
Valencia
Country
Spain
Facility Name
1901
City
Taipei
Country
Taiwan
Facility Name
1902
City
Taipei
Country
Taiwan
Facility Name
1903
City
Taipei
Country
Taiwan
Facility Name
1003
City
Bournemouth
Country
United Kingdom
Facility Name
1004
City
Bradford
Country
United Kingdom
Facility Name
1001
City
London
Country
United Kingdom
Facility Name
1005
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

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Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

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