Multiple MyelomaPhase 2NCT01913730
Maintenance Therapy With Subcutaneous Bortezomib
A Phase 2 study testing Bortezomib and Dexamethasone in people with Multiple Myeloma, run by European Myeloma Network B.V. at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2013to 7 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Bortezomib, Dexamethasone
- Keywords
- Multiple Myeloma, Refractory, Relapsed
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| No prolonged therapy is scheduled | No intervention | Not described |
| 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. Receives: Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Measured: 5 years
Secondary outcomes (10)
Survival
Overall Survival Progression Free Survival
Measured: 5 years
Response
Objective overall response rate (ORR)
Measured: 5 years
Response
Duration of response
Measured: 5 years
Response
Time to response
Measured: 5 years
Response
Time to the next anti-myeloma therapy (TNT)
Measured: 5 years
Response
TTP measured from the beginning of the salvage treatment
Measured: 5 years
Response
Role of the type of salvage treatment
Measured: 5 years
Response
Role of previous treatments
Measured: 5 years
Response
Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs)
Measured: 5 years
Response
Exploratory assessment on prognosis (ISS, age and FISH abnormalities)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2021
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- Fondazione EMN Italy Onlus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913730
- Sponsor's protocol ID
- 26866138-MMY-2084
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2013
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01913730
- Acronym / sponsor ID
- 26866138-MMY-2084
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Refractory, Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- Fondazione EMN Italy Onlus
- Study start
- Nov 2013 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No prolonged therapy is scheduled | No intervention | – |
| Bortezomib Dexamethasone (Biochemical relapse) | Experimental | Drug: Bortezomib, Drug: DexamethasonePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib | Drug | Bortezomib Dexamethasone (Biochemical relapse) |
| Dexamethasone | Drug | Bortezomib Dexamethasone (Biochemical relapse) |
Primary outcome
Time to Progression
Time frame: 5 years
10 secondary outcomes
Survival
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Response
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib and Dexamethasone in people with Multiple Myeloma, run by European Myeloma Network B.V. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.