Bortezomib as First Salvage Therapy for Myeloma Patients Previously Exposed to Bortezomib as Initial Treatment.

NCT02797041 | Unknown DMC

• 1 other identifier: CentroROB
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations. Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Bortezomib; Relapsed multiple myeloma; Rechallenge

Outcome Measures

Primary Outcomes (2)

• Response rate

  International Myeloma Study Group Criteria

  March, 31, 2016

• Adverse events

  Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)

  March,31, 2016

Secondary Outcomes (4)

• Progression free survival 1 and 2

  March, 31, 2016

• Time to next treatment

  March, 31, 2016

• Overall survival

  March, 31, 2016

• Secondary primary malignancies

  March, 31, 2016

Interventions

Bortezomib DRUG

Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment

Also known as: No other drugs evaluated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment and that after their first line treatment's relapse received again a bortezomib-based treatment

You may qualify if:

• Patients satisfying all of the following criteria will be enclosed in the study:
• Age ≥ 18 years old
• Patients with documented multiple myeloma that received bortezomib-based regimens as first line treatment (both in clinical practice or clinical trials) even if followed by ASCT (Autologous stem cell transplantation) and that after their first line treatment's clinical or biochemical relapse received again a bortezomib-based treatment according to current clinical practice and/or Italian Societies of Hematology (SIE), Experimental Hematology (SIES) and Transplantation (GITMO), International Myeloma Working group (IMWG) and/or National Cancer Comprehensive Cancer Network (NCCN) guidelines/treatment recommendations.
• Signed Informed Consent form if feasible

You may not qualify if:

• Patients not treated with bortezomib as first line therapy and/or second line therapy
• Patients with more than one relapse before bortezomib re-use
• Patients unable to understand and sign Informed Consent form (see exceptions listed in section 8 "Informed consent")
• Patients who received bortezomib at relapse in combination with any investigational drug not-approved.

Sponsors & Collaborators

• IRCCS Centro di Riferimento Oncologico della Basilicata: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pellegrino Musto, MD

  IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 13, 2016
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share