Multiple MyelomaPhase 2NCT00201695
Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma
A Phase 2 study testing Doxil®, Vincristine and Dexamethasone in people with Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%. 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?
- Doxil®, Vincristine and Dexamethasone
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have Multiple Myeloma
- No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma
- ECOG performance status must be 0-2
Who cannot join
- Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan.
- QT interval ≥480 msec on baseline ECG.
- No history of cardiac disease.
- Pregnant or breast-feeding.
- No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil.
- History of prior or concurrent malignancy or myelodysplasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Pegylated Liposomal Doxorubicin (Doxil), Vincristine, and Dexamethasone (DVd) in Combination With Arsenic Trioxide (Trisenox) in Untreated Patients With Symptomatic Multiple Myeloma
This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.
Read the detailed description
Rationale: The chemotherapy combination of doxorubicin, vincristine and dexamethasone (DVd) has been used with some efficacy in patients with multiple myeloma. However, DVd's efficacy is primarily considered palliative for patients with this condition. The current study adds arsenic trioxide to the DVd combo to assess if all of the treatments together improve patient outcomes. Previous studies suggest that arsenic trioxide may enhance the efficacy of specific chemotherapy agents including those in DVd; however, research in people has not yet demonstrated this improved effectiveness. Because the safety of arsenic trioxide has been tested in this patient population, this phase II study will gather more information about safety and also measure efficacy through various measures.
Purpose: This study will evaluate the safety and efficacy of doxorubicin, vincristine and dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma. The biology of the tumor and other molecular changes will also be assessed in patients through collections of blood and marrow samples.
Treatment: Patients in this study will receive arsenic trioxide, doxorubicin, vincristine and dexamethasone. During the first five days of the study, patients will be given arsenic trioxide each day through an intravenous infusion. No treatments will be provided on days six and seven. After this first week, patients will then receive study drugs on the following schedule every four weeks: doxorubicin and vincristine on day one, dexamethasone on days one through four, and arsenic trioxide twice each week. This schedule can be repeated up to four times for a total of approximately four months. Several tests and exams will be given throughout the study to closely monitor patients. Supportive care will be provided to help regulate side effects from study drugs and maintain quality of life in patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
- Conditions
- Multiple Myeloma
- Being tested
- Doxil®, Vincristine, Dexamethasone, Arsenic Trioxide
- Keywords
- Untreated Patients, Symptomatic
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxil®Drug
Also called Doxorubicin HCL liposome injection
40 mg/m2 IV day 1
VincristineDrug
Also called Oncovin
1.4 mg/m2 (maximum 2 mg) IV day 1
DexamethasoneDrug
Also called DVd
40 mg PO days 1-4
Arsenic TrioxideDrug
Also called Trisenox, ATO
0.25 mg/kg IV over 1-4 hours twice per week, week 1-4 of each cycle (i.e., days 1 and 4; 8 and 11; 15 and 18; 22 and 25)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM)
Measured: 2004-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2006
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Hofmeister, Ohio State University Comprehensive Cancer Center
- Investigators
- Craig Hofmeister, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201695
- Sponsor's protocol ID
- OSU-0354
- Status last verified
- Jun 2015
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hofmeister CC, Jansak B, Denlinger N, Kraut EH, Benson DM, Farag SS. Phase II clinical trial of arsenic trioxide with liposomal doxorubicin, vincristine, and dexamethasone in newly diagnosed multiple myeloma. Leuk Res. 2008 Aug;32(8):1295-8. doi: 10.1016/j.leukres.2007.10.020. Epub 2007 Dec 21.
PubMed 18082257
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pegylated Liposomal Doxorubicin (Doxil), Vincristine, and Dexamethasone (DVd) in Combination With Arsenic Trioxide (Trisenox) in Untreated Patients With Symptomatic Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00201695
- Acronym / sponsor ID
- OSU-0354
- Conditions
- Multiple Myeloma
- Keywords
- Untreated Patients, Symptomatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Sep 2005 (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 study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%.
Detailed description
Rationale: The chemotherapy combination of doxorubicin, vincristine and dexamethasone (DVd) has been used with some efficacy in patients with multiple myeloma. However, DVd's efficacy is primarily considered palliative for patients with this condition. The current study adds arsenic trioxide to the DVd combo to assess if all of the treatments together improve patient outcomes. Previous studies suggest that arsenic trioxide may enhance the efficacy of specific chemotherapy agents including those in DVd; however, research in people has not yet demonstrated this improved effectiveness. Because the safety of arsenic trioxide has been tested in this patient population, this phase II study will gather more information about safety and also measure efficacy through various measures.
Purpose: This study will evaluate the safety and efficacy of doxorubicin, vincristine and dexamethasone plus arsenic trioxide in untreated patients with symptomatic multiple myeloma. The biology of the tumor and other molecular changes will also be assessed in patients through collections of blood and marrow samples.
Treatment: Patients in this study will receive arsenic trioxide, doxorubicin, vincristine and dexamethasone. During the first five days of the study, patients will be given arsenic trioxide each day through an intravenous infusion. No treatments will be provided on days six and seven. After this first week, patients will then receive study drugs on the following schedule every four weeks: doxorubicin and vincristine on day one, dexamethasone on days one through four, and arsenic trioxide twice each week. This schedule can be repeated up to four times for a total of approximately four months. Several tests and exams will be given throughout the study to closely monitor patients. Supportive care will be provided to help regulate side effects from study drugs and maintain quality of life in patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have Multiple Myeloma
- No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma
- ECOG performance status must be 0-2
Key exclusion criteria (6 listed)
- Resting left ventricular cardiac ejection fraction ≥50% by echo or MUGA scan.
- QT interval ≥480 msec on baseline ECG.
- No history of cardiac disease.
- Pregnant or breast-feeding.
- No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil.
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 |
|---|---|---|
| Doxil®Also: Doxorubicin HCL liposome injection40 mg/m2 IV day 1 | Drug | – |
| VincristineAlso: Oncovin1.4 mg/m2 (maximum 2 mg) IV day 1 | Drug | – |
| DexamethasoneAlso: DVd40 mg PO days 1-4 | Drug | – |
| Arsenic TrioxideAlso: Trisenox, ATO0.25 mg/kg IV over 1-4 hours twice per week, week 1-4 of each cycle (i.e., days 1 and 4; 8 and 11; 15 and 18; 22 and 25) | Drug | – |
Primary outcome
Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM)
Time frame: 2004-2008
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 10 Jun 2015.
- Results publication: PubMed 18082257Hofmeister CC, Jansak B, Denlinger N, Kraut EH, Benson DM, Farag SS. Phase II clinical trial of arsenic trioxide with liposomal doxorubicin, vincristine, and dexamethasone in newly diagnosed multiple myeloma. Leuk Res. 2008 Aug;32(8):1295-8. doi: 10.1016/j.leukres.2007.10.020. Epub 2007 Dec 21.
- JameslineLink 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.
Craig Hofmeister, MD principal investigator
Ohio State University
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 Doxil®, Vincristine and Dexamethasone in people with Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 3 inclusion and 6 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 10 Jun 2015. 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 United States. 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?
Assess the ability of DVd plus arsenic trioxide to achieve an overall response (complete and partial) rate in patients with untreated Multiple myeloma(MM) (time frame: 2004-2008). 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 NCT00201695, which also lists 1 linked publication.
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 10 Jun 2015.