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NCT Number: NCT03602755

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H. Santiago (CHUS), Santiago de Compostela, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Acronym: RETRO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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