Multiple MyelomaNCT01021592

Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: bortezomib
Type of treatment: Injection or infusion
How many people: 140 participants
Where: No sites listed yet
Study dates: Mar 2007to Jul 2008
Phase: Observational
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

Study population: Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.

Who may be able to join

Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma
Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included

Who cannot join

Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity
Patients with severe hepatic impairment
Pregnant women

About this study

Official title: Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study

This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.

Read the detailed description

Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered

Conditions: Multiple Myeloma
Being tested: bortezomib
Keywords: Velcade, QoL, Proteasome inhibitor, Bortezomib, EORTC QLQ C30, EQ 5D
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bortezomibDrug
Injection into a vein 1.3 mg/m2 twice a week for 21 days

Study groups in NCT01021592
Study group	Role	What they receive
001		Not described Receives: Drug: bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
Measured: Before the first, after the fourth and at the last IV cycle of bortezomib

Secondary outcomes (4)

Relationship between the primary outcome and the complete remission (CR) rate
Measured: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the overall response rate
Measured: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the time to response
Measured: Before the first, after the fourth and at the last IV cycle of bortezomib
Adverse events
Measured: Every 3 week cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jul 2008

First posted30 Nov 2009 (estimated)
Study startMar 2007
Primary completionJul 2008
Study completionJul 2008

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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01021592
Sponsor's protocol ID: CR012961
Other IDs: BOR-KOR-11
Status last verified: Dec 2014
First submitted: 25 Nov 2009
Last updated: 23 Dec 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
ClinicalTrials.gov ID: NCT01021592
Acronym / sponsor ID: CR012961
Conditions: Multiple Myeloma
Keywords: Velcade, QoL, Proteasome inhibitor, Bortezomib, EORTC QLQ C30, EQ 5D
Study type: Observational
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 30 Nov 2009 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
001	–	Drug: bortezomib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.

Key inclusion criteria (2 listed)

Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma
Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included

Key exclusion criteria (3 listed)

Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity
Patients with severe hepatic impairment
Pregnant women

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
bortezomibInjection into a vein 1.3 mg/m2 twice a week for 21 days	Drug	001

Primary outcome

The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib

4 secondary outcomes

Relationship between the primary outcome and the complete remission (CR) rate
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the overall response rate
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the time to response
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Adverse events
Time frame: Every 3 week cycle

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 23 Dec 2014.
Evaluation in Improvement of Quality of Life in Patients with Multiple Myeloma Using Velcade® (bortezomib)Link provided by the sponsor.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Janssen Korea, Ltd. Clinical Trial study director

Janssen Korea, Ltd.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea.

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 2 inclusion and 3 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib (time frame: Before the first, after the fourth and at the last IV cycle of bortezomib). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021592.

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 23 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.