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

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ClinicalTrials.gov Identifier: NCT02797041
Recruitment Status : Unknown
Verified June 2016 by Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata.
Recruitment status was:  Active, not recruiting
First Posted : June 13, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata

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.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: Bortezomib

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: REal Life, Retrospective Study of BOrtezomib Use as secoND Treatment for Myeloma Patients Previously Exposed to Bortezomib-based Therapies as First Line
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib


Intervention Details:
  • Drug: Bortezomib
    Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment
    Other Name: No other drugs evaluated


Primary Outcome Measures :
  1. Response rate [ Time Frame: March, 31, 2016 ]
    International Myeloma Study Group Criteria

  2. Adverse events [ Time Frame: March,31, 2016 ]
    Types (haematological and non hematological) and degree (Common terminology criteria adverse criteria)


Secondary Outcome Measures :
  1. Progression free survival 1 and 2 [ Time Frame: March, 31, 2016 ]
  2. Time to next treatment [ Time Frame: March, 31, 2016 ]
  3. Overall survival [ Time Frame: March, 31, 2016 ]
  4. Secondary primary malignancies [ Time Frame: March, 31, 2016 ]
    Types and incidence



Information from the National Library of Medicine

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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:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT02797041


Sponsors and Collaborators
IRCCS Centro di Riferimento Oncologico della Basilicata
Investigators
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Principal Investigator: Pellegrino Musto, MD IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Pz), Italy

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Responsible Party: Pellegrino Musto, Scientific Director, IRCCS Centro di Riferimento Oncologico della Basilicata
ClinicalTrials.gov Identifier: NCT02797041     History of Changes
Other Study ID Numbers: CentroROB
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Central database of single patients

Keywords provided by Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata:
Multiple myeloma
Bortezomib
Relapsed multiple myeloma
Rechallenge

Additional relevant MeSH terms:
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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
Bortezomib
Antineoplastic Agents