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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01913730
Other study ID # 26866138-MMY-2084
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2013
Est. completion date September 7, 2023

Study information

Verified date December 2023
Source European Myeloma Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 7, 2023
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient is of a legally consenting age as defined by local regulations. 2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. 3. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 4. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy. 5. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of bortezomib therapy. 6. Patient was previously diagnosed with multiple myeloma based on standard criteria. 7. Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease. 8. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease. 9. Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib. 10. Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease Exclusion Criteria: 1. Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk. 2. Pregnant or lactating females 3. Known positive for HIV or active infectious hepatitis type A, B or C 4. Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 5. Infiltrative pulmonary disease.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bortezomib

Dexamethasone


Locations

Country Name City State
Italy Irccs Crob Rionero in Vulture Potenza

Sponsors (2)

Lead Sponsor Collaborator
European Myeloma Network Fondazione EMN Italy Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Progression 5 years
Secondary Survival Overall Survival Progression Free Survival 5 years
Secondary Response Objective overall response rate (ORR) 5 years
Secondary Response Duration of response 5 years
Secondary Response Time to response 5 years
Secondary Response Time to the next anti-myeloma therapy (TNT) 5 years
Secondary Response TTP measured from the beginning of the salvage treatment 5 years
Secondary Response Role of the type of salvage treatment 5 years
Secondary Response Role of previous treatments 5 years
Secondary Response Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs) 5 years
Secondary Response Exploratory assessment on prognosis (ISS, age and FISH abnormalities) 5 years
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