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A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
PharmaMar
ClinicalTrials.gov Identifier:
NCT00229203
First received: September 27, 2005
Last updated: December 14, 2009
Last verified: December 2009
History of Changes
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Plitidepsin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in 10 centers in Spain and USA between June 2004 and June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Plitidepsin Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
Plitidepsin + Dexamethasone Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

Participant Flow:   Overall Study
    Plitidepsin     Plitidepsin + Dexamethasone  
STARTED     32     19  
COMPLETED     0     0  
NOT COMPLETED     32     19  
Progressive disease                 18                 9  
Toxicity                 6                 1  
Death                 4                 2  
--                 3                 3  
Withdrawal by Subject                 1                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Plitidepsin Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
Plitidepsin + Dexamethasone Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
Total Total of all reporting groups

Baseline Measures
    Plitidepsin     Plitidepsin + Dexamethasone     Total  
Number of Participants  
[units: participants]
 		  32     19     51  
Age  
[units: years]
Median ( Full Range ) 		  66  
  ( 47 to 82 )   		  63  
  ( 47 to 86 )   		  64.0  
  ( 47 to 86 )  
Gender  
[units: participants]
 		     
Female     15     6     21  
Male     17     13     30  
ECOG PS [1]
[units: patients]
 		     
0 Units of Scale     6     6     12  
1 Units of Scale     18     9     27  
2 Units of Scale     8     4     12  
[1] ECOG PS: Eastern Cooperative Oncology Group Performance Status This scale is used by doctors to assess how a patient's disease is progressing, how the disease affects the daily living abilities of patients, and determine appropriate treatment and prognosis. Scale points: 0, 1, 2, 3, 4 & 5; 0: Fully active, able to carry on all pre-disease performance without restriction, and 5: Death



  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response   [ Time Frame: Every 2 weeks until progression or death occurs. ]
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2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed. ]
  Show Outcome Measure 2

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed. ]
  Show Outcome Measure 3

4.  Secondary:   Number of Patients With Overall Survival (OS)   [ Time Frame: Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed. ]
  Show Outcome Measure 4


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone

Reporting Groups
  Description
Plitidepsin Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
Plitidepsin + Dexamethasone Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

Serious Adverse Events
    Plitidepsin     Plitidepsin + Dexamethasone  
Total, serious adverse events      
# participants affected / at risk     32/51 (62.75%)     11/19 (57.89%)  
Cardiac disorders      
Atrial fibrillation      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Atrial flutter      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Cardiac failure congestive      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Cardiomyopathy NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Pulmonary oedema NOS      
# participants affected / at risk     1/51 (1.96%)     1/19 (5.26%)  
Gastrointestinal disorders      
Abdominal pain upper      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Gastrointestinal haemorrhage NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
General disorders      
Catheter site haemorrhage      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Fatigue      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Injection site cellulitis      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Multi-organ failure      
# participants affected / at risk     2/51 (3.92%)     0/19 (0.00%)  
Pyrexia      
# participants affected / at risk     7/51 (13.73%)     3/19 (15.79%)  
Sudden death      
# participants affected / at risk     1/51 (1.96%)     1/19 (5.26%)  
Hepatobiliary disorders      
Cholestasis      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Immune system disorders      
Hypersensitivity NOS      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Infections and infestations      
Bronchitis acute NOS      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Herpes zoster      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Pneumonia NOS      
# participants affected / at risk     7/51 (13.73%)     2/19 (10.53%)  
Respiratory tract infection NOS      
# participants affected / at risk     7/51 (13.73%)     2/19 (10.53%)  
Septic shock      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Upper respiratory tract infection NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Urinary tract infection NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Investigations      
Blood creatine phosphokinase increased      
# participants affected / at risk     0/51 (0.00%)     2/19 (10.53%)  
Metabolism and nutrition disorders      
Hypercalcaemia      
# participants affected / at risk     2/51 (3.92%)     1/19 (5.26%)  
Musculoskeletal and connective tissue disorders      
Bone pain      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Muscle weakness NOS      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Myalgia      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Myopathy      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Myopathy toxic      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Nervous system disorders      
Cerebrovascular accident      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Cervical cord compression      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Cognitive disorder      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Metabolic encephalopathy NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Parkinsonism      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Quadriparesis      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Psychiatric disorders      
Confusional state      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Renal and urinary disorders      
Acute pre-renal failure      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Renal failure NOS      
# participants affected / at risk     3/51 (5.88%)     1/19 (5.26%)  
Respiratory, thoracic and mediastinal disorders      
Acute pulmonary oedema      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Bronchospasm NOS      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Dyspnoea NOS      
# participants affected / at risk     2/51 (3.92%)     1/19 (5.26%)  
Pleural effusion      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Pneumonitis NOS      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  
Pulmonary embolism      
# participants affected / at risk     0/51 (0.00%)     1/19 (5.26%)  
Respiratory failure      
# participants affected / at risk     3/51 (5.88%)     1/19 (5.26%)  
Vascular disorders      
Poor peripheral circulation      
# participants affected / at risk     1/51 (1.96%)     0/19 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked 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. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
32 patients were treated with plitidepsin as single agent;afterwards 19 of them were treated with plitidepsin+dexamethasone combination.Therefore 32+19=51 is the no. patients at risk for plitidepsin and 19 is no. of patients at risk for dexamethasone  


Results Point of Contact:  
Name/Title: Claudia Silvia Corrado M.D.
Organization: PharmaMar USA Inc
phone: 1 212 201 6770
e-mail: cscorrado@pharmamar.com


No publications provided


Responsible Party: PharmaMar USA Inc.
ClinicalTrials.gov Identifier: NCT00229203     History of Changes
Other Study ID Numbers: APL-B-014-03
Study First Received: September 27, 2005
Results First Received: August 31, 2009
Last Updated: December 14, 2009
Health Authority: United States: Food and Drug Administration