Multiple MyelomaPhase 2NCT00319865
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Velcade, Thalidomide and Adriamycin in people with Multiple Myeloma, run by Korean Multiple Myeloma Working Party at 1 site in South Korea.
Trial summary
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially. Read more about this study
- Who is it for?
- Ages 0 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Velcade, Thalidomide and Adriamycin
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2005to Sep 2008
- 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 0 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
- Presence of measureble disease : serum M-protein > 1g/dL or urine M-protein > 400mg/day
- Age < 75
- Performance status </= ECOG 2
- Expected survival > 6 months
- who signs the informed consent
Who cannot join
- known hypersensitivity to thalidomide or dexamethasone
- known refractoriness to thalidomide + dexamethasone
- Previous Velcade therapy
- Sepsis
- Woman in reproductive age
- Serum creatinine > 2 mg/dL ; 24 hour creatinine clearance < 30 ml/min; past medical history of kidney transplatation
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- Peripheral neuropathy >/= grade 2
- Recurrent DVT or pulmonary embolism
- Cardiac ejection fraction <0.5 : Severe conduction disorder
- Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
- Active ulcers in gastrofiberscope
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Hospital
Inchon, 405-220
Jae Hoon Lee, M.D., 82-32-460-2186, jhlee@gilhoospital.com
Hee Keun Kang, R.N., 82-32-460-3655, happy@gilhospital.com
About this study
Official title: PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
Read the detailed description
Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.
We desined prospective multicenter phase 2 study using these combination sequentially.
- Conditions
- Multiple Myeloma
- Being tested
- Velcade, Thalidomide, Adriamycin, Dexamethasone
- Keywords
- Multiple Myeloma Relapsed
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
ThalidomideDrug
AdriamycinDrug
DexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of PAD induction Therapy
Secondary outcomes (3)
Response rate of PAD followed by Thal/Dex maintenance
Progression free survival and Overall survival of PAD/Thal-Dex.
To evaluate toxicities of PAD/Thal-Dex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startNov 2005
- Study completionSep 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants
Sponsor and investigators
- Lead sponsor
- Korean Multiple Myeloma Working Party
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Jae Hoon Lee, M.D., Principal investigator, Korean Multiple Myeloma Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319865
- Sponsor's protocol ID
- KMM55
- Status last verified
- Apr 2006
- First submitted
- 28 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00319865
- Acronym / sponsor ID
- KMM55
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants
- Lead sponsor
- Korean Multiple Myeloma Working PartyUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Nov 2005
- Study completion
- Sep 2008
- First posted
- 27 Apr 2006 (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.
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
Detailed description
Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.
We desined prospective multicenter phase 2 study using these combination sequentially.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
- Presence of measureble disease : serum M-protein > 1g/dL or urine M-protein > 400mg/day
- Age < 75
- Performance status </= ECOG 2
- Expected survival > 6 months
Key exclusion criteria (11 listed)
- known hypersensitivity to thalidomide or dexamethasone
- known refractoriness to thalidomide + dexamethasone
- Previous Velcade therapy
- Sepsis
- Woman in reproductive age
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 |
|---|---|---|
| Velcade | Drug | – |
| Thalidomide | Drug | – |
| Adriamycin | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Response rate of PAD induction Therapy
3 secondary outcomes
Response rate of PAD followed by Thal/Dex maintenance
Progression free survival and Overall survival of PAD/Thal-Dex.
To evaluate toxicities of PAD/Thal-Dex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
- Korean Society of HematologyLink provided by the sponsor.
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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.
Jae Hoon Lee, M.D. principal investigator
Korean Multiple Myeloma Working Party
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 Velcade, Thalidomide and Adriamycin in people with Multiple Myeloma, run by Korean Multiple Myeloma Working Party at 1 site in South 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Apr 2006. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hoon Lee, M.D. (82-32-460-2186, jhlee@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of PAD induction Therapy. 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 27 Apr 2006.