Overview

Maintenance Therapy With Subcutaneous Bortezomib

Status:
Active, not recruiting
Trial end date:
2021-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Myeloma Network
Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators:
Fondazione EMN Italy Onlus
Fondazione Neoplasie Sangue Onlus
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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consent may be withdrawn by the patient at any time without prejudice to their future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.