Maintenance Therapy With Subcutaneous Bortezomib

Multiple Myeloma Clinical Trial

Official title:

A PHASE II MULTI-CENTRE, RANDOMIZED, OPEN LABEL STUDY OF PROLONGED THERAPY WITH SC BORTEZOMIB TWICE MONTHLY ASSOCIATED WITH DEXAMETHASONE, IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER SALVAGE WITH BORTEZOMIB-BASED THERAPY.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913730
• Other study ID #: 26866138-MMY-2084
• Status: Completed
• Phase: Phase 2
• 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
• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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