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A Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma in Spain (RETRO)

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ClinicalTrials.gov Identifier: NCT03602755
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.

Condition or disease
Multiple Myeloma

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
Patients with newly diagnosed transplant-ineligible MM
Adult Patients with newly diagnosed MM who were not suitable candidates for ASCT who started first-line treatment for the study disease in a routine clinical practice setting between 2012 and 2016, inclusive.



Primary Outcome Measures :
  1. Description of the first-line treatment regimens [ Time Frame: Up to approximately 5 months ]
    Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT)


Secondary Outcome Measures :
  1. Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain [ Time Frame: Up to approximately 5 months ]
    Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each staging group: Stage I, II and III (ISS) and ISS R

  2. Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain [ Time Frame: Up to approximately 5 months ]
    Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each MM subtype group

  3. Progression-free survival (PFS) [ Time Frame: Up to approximately 5 months ]
    Is described as time from start of treatment until disease progression or death

  4. Overall survival (OS) [ Time Frame: Up to approximately 5 months ]
    Is described as time from start of the treatment until death

  5. Overall response rate [ Time Frame: Up to approximately 5 months ]
    Is based on IMWG criteria

  6. Duration of response [ Time Frame: Up to approximately 5 months ]
    Is described as time from start of the treatment until end of first line treatment

  7. Patients who receive second-line treatment [ Time Frame: Up to approximately 5 months ]
    Proportion of patients who receive second-line treatment

  8. Patients who underwent dose adjustment or switched treatment [ Time Frame: Up to approximately 5 months ]
    Proportion of patients who underwent dose adjustment or switched treatment

  9. Patients who discontinued treatment [ Time Frame: Up to approximately 5 months ]
    Proportion of patients who discontinued treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In total, 400 patients with a de novo diagnosis of multiple myeloma who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive, in a routine clinical practice setting in Spain, will be included.
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive.
  • Patients who give informed consent before data collection begins.

Exclusion Criteria:

  • Patients who participated in a clinical trial for first-line treatment of MM during the study period.
  • Patients who are alive, but do not give their IC.
  • Patients with MM who did not receive treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602755


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Spain
H. Santiago (CHUS) Active, not recruiting
Santiago de Compostela, A Coruña, Spain, 15706
H. Txagorritxu Recruiting
Vitoria, Alava, Spain, 01009
H. Cabueñes Not yet recruiting
Gijón, Asturias, Spain, 33394
H. Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
H. Son Espases Recruiting
Palma, Baleares, Spain, 07120
ICO Duran i Reynals Active, not recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
H. Althaia Recruiting
Manresa, Barcelona, Spain, 08243
H. Mutua de Terrassa Recruiting
Terrasa, Barcelona, Spain, 08221
H. Jerez Recruiting
Jerez de la Frontera, Cadiz, Spain, 11408
H. Alvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
H. del Mar Recruiting
Barcelona, Spain, 0 8003
H. Josep Trueta Active, not recruiting
Girona, Spain, 17007
H. Arnau de Villanova Recruiting
Lleida, Spain, 25198
H- Virgen de la Victoria Recruiting
Malaga, Spain, 29010
H. Carlos Haya Recruiting
Malaga, Spain, 29010
H. Ourense (CHOU) Active, not recruiting
Orense, Spain, 32005
H. Virgen Macarena Active, not recruiting
Sevilla, Spain, 41009
H. Joan XXIII Active, not recruiting
Tarragona, Spain, 43005
H. Dr. Peset Recruiting
Valencia, Spain, 46017
H. La Fe Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Celgene
Investigators
Study Director: Marta Durán, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03602755     History of Changes
Other Study ID Numbers: NDS-MM-002
U1111-1215-4398 ( Other Identifier: WHO )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Transplant
Multiple Myeloma
Spain

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases