Maintenance Therapy With Subcutaneous Bortezomib

NCT01913730 | Completed Phase 2

• 1 other identifier: 26866138-MMY-2084
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Refractory; Relapsed

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  5 years

Secondary Outcomes (10)

• Survival

  5 years

• Response

  5 years

• Response

  5 years

• Response

  5 years

• Response

  5 years

Study Arms (2)

No prolonged therapy is scheduled

NO INTERVENTION

Bortezomib Dexamethasone (Biochemical relapse)

EXPERIMENTAL

Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 4 VD cycles will be administered: Bortezomib (SC) and Dexamethasone (PO) weekly.

Drug: Bortezomib; Drug: Dexamethasone

Interventions

Bortezomib DRUG

Bortezomib Dexamethasone (Biochemical relapse)

Dexamethasone DRUG

Bortezomib Dexamethasone (Biochemical relapse)

Eligibility Criteria

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

You may qualify if:

• Patient is of a legally consenting age as defined by local regulations.
• Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• 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.
• 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.
• Patient was previously diagnosed with multiple myeloma based on standard criteria.
• 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.
• Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.
• Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib.
• Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease

You may not qualify if:

• 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.
• Pregnant or lactating females
• Known positive for HIV or active infectious hepatitis type A, B or C
• Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0
• Infiltrative pulmonary disease.

Sponsors & Collaborators

• European Myeloma Network B.V.: lead
• Fondazione EMN Italy Onlus: collaborator

Study Sites (1)

Irccs Crob

Rionero in Vulture, Potenza, Italy

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bortezomib; Dexamethasone

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: August 1, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2021
• Study Completion: September 7, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

IT (1)