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Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plitidepsin+Dexamethasone | Experimental | plitidepsin + dexamethasone combination |
|
| Dexamethasone | Active Comparator | dexamethasone single agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plitidepsin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Óscar F. Ballester, M.D. | Edwards Comprehensive Cancer Center, Marshall University (Huntington) | Principal Investigator |
| Rubén Niesvizky, M.D. | NY Presbyterian Hosp. - Cornell University - NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1107 | Tuscaloosa | Alabama | United States | |||
| 1103 |
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A total of 255 patients were enrolled. 171 Group A (Plitidepsin in combination with DXM) and 84 Group B (DXM alone).
Enrolled patients between 29Jun10 and 19May15 (Last randomization). The first dose of the first patient was given on 19May15 and the last dose of the last patient was given on 07Aug17.
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| ID | Title | Description |
|---|---|---|
| FG000 | Plitidepsin+Dexamethasone | plitidepsin + dexamethasone combination plitidepsin + dexamethasone: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2017 | Jul 27, 2020 |
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|
| Dexamethasone | Drug | 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks. |
|
|
| 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 |
| 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. | 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 |
| Overall Survival | Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact | From randomization to the death due to any cause,assessed up to 5 years |
| 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 | From randomization to the death due to any cause,assessed up to 12 months |
| 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 | From randomization to the death due to any cause,assessed up to 24 months |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| 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 | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| Los Angeles |
| California |
| United States |
| 1105 | Jacksonville | Florida | United States |
| 1102 | New York | New York | United States |
| 1104 | Canton | Ohio | United States |
| 108 | Adelaide | Australia |
| 102 | Canberra | Australia |
| 101 | Geelong | Australia |
| 105 | Parkville | Australia |
| 106 | Perth | Australia |
| 104 | South Brisbane | Australia |
| 109 | Woodville | Australia |
| 202 | Graz | Austria |
| 204 | Innsbruck | Austria |
| 203 | Salzburg | Austria |
| 201 | Vienna | Austria |
| 205 | Vienna | Austria |
| 208 | Vienna | Austria |
| 304 | Bruges | Belgium |
| 301 | Brussels | Belgium |
| 303 | Brussels | Belgium |
| 302 | Ghent | Belgium |
| 502 | Brno | Czechia |
| 503 | Hradec Králové | Czechia |
| 501 | Prague | Czechia |
| 601 | Lille | France |
| 602 | Nantes | France |
| 606 | Rouen | France |
| 604 | Vandœuvre-lès-Nancy | France |
| 709 | Düsseldorf | Germany |
| 705 | Essen | Germany |
| 706 | Frankfurt | Germany |
| 707 | Frankfurt | Germany |
| 708 | Freiburg im Breisgau | Germany |
| 703 | Heidelberg | Germany |
| 702 | München | Germany |
| 704 | Würzburg | Germany |
| 1301 | Athens | Greece |
| 1303 | Pátrai | Greece |
| 1302 | Thessaloniki | Greece |
| 1401 | Dublin | Ireland |
| 806 | Bari | Italy |
| 801 | Genova | Italy |
| 805 | Reggio Emilia | Italy |
| 803 | Rozzano | Italy |
| 804 | San Giovanni Rotondo | Italy |
| 802 | Torino | Italy |
| 901 | Rotterdam | Netherlands |
| 902 | Rotterdam | Netherlands |
| 1601 | Christchurch | New Zealand |
| 1602 | Takapuna | New Zealand |
| 1704 | Opole | Poland |
| 1703 | Warsaw | Poland |
| 1802 | Braga | Portugal |
| 1801 | Porto | Portugal |
| 2001 | San Juan | Puerto Rico |
| 1502 | Anyang | South Korea |
| 1501 | Daejeon | South Korea |
| 1507 | Hwasun | South Korea |
| 1506 | Incheon | South Korea |
| 1505 | Jeonju | South Korea |
| 1508 | Seongnam | South Korea |
| 1503 | Seoul | South Korea |
| 1504 | Seoul | South Korea |
| 1509 | Seoul | South Korea |
| 1201 | Barcelona | Spain |
| 1203 | Barcelona | Spain |
| 1209 | Barcelona | Spain |
| 1207 | Madrid | Spain |
| 1210 | Madrid | Spain |
| 1206 | Murcia | Spain |
| 1204 | Palma de Mallorca | Spain |
| 1208 | Salamanca | Spain |
| 1202 | San Sebastián | Spain |
| 1205 | Valencia | Spain |
| 1901 | Taipei | Taiwan |
| 1902 | Taipei | Taiwan |
| 1903 | Taipei | Taiwan |
| 1003 | Bournemouth | United Kingdom |
| 1004 | Bradford | United Kingdom |
| 1001 | London | United Kingdom |
| 1005 | Nottingham | United Kingdom |
| FG001 | Dexamethasone | dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Plitidepsin+Dexamethasone | plitidepsin + dexamethasone combination plitidepsin + dexamethasone: 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. |
| BG001 | Dexamethasone | dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| ECOG PS | ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active, able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours PS 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours PS 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead | Count of Participants | Participants |
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| MM type at diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Durie-Salmon stage at diagnosis | Stage I: small number of myeloma cells. All are present:Hemoglobin>100 g/L;Blood calcium<2.8 mmol/L;No areas of bone damage or a solitary plasmacytoma of the bone;IgG<50 g/L;IgA<30 g/L;Urine M-protein<4 g Stage II: Moderate number of myeloma cells. The features are between stage 1 and 3 Stage III: Large number of myeloma cells. One/more are present: Hemoglobin<85 g/L;Blood calcium>2.8 mmol/L;Several areas of bone damage;IgG>70 g/L;IgA>50 g/L;Urine M-protein>12 g Substage A: Kidney function is normal. Creatinine<180 µmol/L. Substage B: Kidney function is abnormal. Creatinine>=180 µmol/L | Count of Participants | Participants |
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| International Staging System at diagnosis | The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level. Stage I: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L. Stage II: Beta-2-microglobulin level less than 3.5 mg/L and Albumin level less than 35 g/L or beta-2-microglobulin level is more than 3.5 mg/L but less than 5.5 mg/L and any albumin level. Stage III: Beta-2-microglobulin is 5.5 mg/L or more and any albumin level. | Count of Participants | Participants |
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| Cytogenetic risk group at diagnosis | NA: not available; ND: not done; UK: unknown. | Count of Participants | Participants |
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| Prior radiotherapy | Count of Participants | Participants |
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| Hb | Median | Full Range | g/dL |
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| Platelets | Median | Full Range | platelets*10^9/L |
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| CrCL | creatinine clearance | Median | Full Range | mL/min |
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| Time from first diagnosis to randomization | Median | Full Range | months |
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| Time from last PD/relapse to first study dose | PD, Progressive disease . | Median | Full Range | weeks |
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| Beta-2 microglobulin | Median | Full Range | mg/L |
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| Number of lines of prior systemic therapy | Median | Inter-Quartile Range | lines |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | 95% Confidence Interval | months | 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 |
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| Primary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| Secondary | 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. | All Randomized Patients | Posted | Median | 95% Confidence Interval | months | 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 |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
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| Secondary | Overall Survival | Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact | All Randomized Patients | Posted | Median | 95% Confidence Interval | months | From randomization to the death due to any cause,assessed up to 5 years |
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| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the death due to any cause,assessed up to 12 months |
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| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the death due to any cause,assessed up to 24 months |
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| Secondary | 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 | Patients with documentation of response | Posted | Median | 95% Confidence Interval | months | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
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| Secondary | 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 | Patients with documentation of response | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months |
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| Secondary | 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 | Patients with documentation of response | Posted | Median | 95% Confidence Interval | months | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
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| Secondary | 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 | Patients with documentation of response | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 6 months |
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| Secondary | 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 | Posted | Count of Participants | Participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years |
|
|
From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plitidepsin+Dexamethasone | plitidepsin + dexamethasone combination plitidepsin + dexamethasone: 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. | 126 | 167 | 99 | 167 | 161 | 167 |
| EG001 | Dexamethasone | dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks. | 74 | 83 | 26 | 83 | 80 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Plasmablastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug administration error | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Plasma cells increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Systolic dysfunction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myopathy toxic | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharma Mar, S.A. | Pharma Mar, S.A. | 0034918466000 | clinicaltrials@pharmamar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2017 | Jul 27, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C098980 | plitidepsin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Czechia |
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| United Kingdom |
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| Portugal |
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| Spain |
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| Greece |
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| New Zealand |
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| Austria |
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| South Korea |
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| Netherlands |
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| Participants |
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dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
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dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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