Multiple MyelomaPhase 2NCT00577512
2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE
A Phase 2 study testing DTPACE in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will… 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?
- DTPACE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with multiple myeloma, treated or untreated, with the presence of one or more of the high risk features as defined below.
- High risk by gene expression profiling at any time prior to enrollment:
- PROLIFERATION signature, MMSET/FGFR3, c-MAF/MAF-B gene groups or
- High risk score based on University of Arkansas Myeloma Institute for Research and Therapy (MIRT) 70 gene model.
- Abnormal metaphase cytogenetics at any time prior to enrollment, or
- Lactate Dehydrogenase (LDH) > 250 IU/L (upper limit normal) at any time prior to enrollment
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- Zubrod ≤ 2, unless due to symptoms of MM.
- Patients must be < 75 years of age at the time of registration.
- Patient must have signed an Institutional Review Board (IRB)-approved informed consent and understand the investigational nature of the study.
- Negative serology for HIV.
- Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, forced vital capacity (FVC), etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
- Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias are ineligible. Ejection fraction by echocardiogram (ECHO) or must be > 40% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the left ventricular ejection fraction (LVEF) must be repeated.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval or if the malignancy is considered much less life threatening than the myeloma.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients must be able to receive full doses of HD-DTPACE, in the opinion of the treating investigator, with the exception that patients with serum creatinine > 1.5 mg/dL will receive modified doses of cisplatin.
Who cannot join
- Fever or active infection requiring intravenous antibiotics within 72 hours from baseline.
- Liver function abnormalities with total bilirubin more than twice the upper limit of normal or aspartate amino transferase (AST)/alanine amino trasferase (ALT) more than three times the upper limit of normal.
- Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of <30ml/min.
- Platelet count < 30,000/mm3, or absolute neutrophil count (ANC) < 1,000/μl.
- Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
- New York Hospital Association (NYHA) Class III or Class IV heart failure.
- Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
- Prior adriamycin exposure > 450 mg/m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 2006-32: Phase II Study of Rapidly Recycled High Dose DTPACE (HD-DTPACE) for Untreated or Previously Treated, High-Risk Multiple Myeloma (MM)
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will have better outcomes.
Read the detailed description
This study has the following goals:
- To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer.
- In subjects achieving a response, to find out how long the response will last.
- To learn more about the side effects of this treatment.
Up to 75 subjects, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at the University of Arkansas for Medical Sciences (UAMS) only.
The treatment in this study is divided into 3 parts
- High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored.
- High dose DTPACE and stem cell re-infusion.
- Velcade, Thalidomide, Dexamethasone (sometimes known as VTD) Maintenance therapy.
- Conditions
- Multiple Myeloma
- Being tested
- DTPACE
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPACEDrug
- Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7
- Thalidomide 200 mg by mouth (PO) Days 1-7
- Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency)
- Adriamycin 15 mg/m2 Days 1-4
- Cyclophosphamide 600 mg/m2 Days 1-4
- Etoposide 60 mg/m2 Days 1-4
| Study group | Role | What they receive |
|---|---|---|
| HD DTPACE | Experimental | DTPACE Receives: Drug: DTPACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.
Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions.
Near Complete Response included all elements of CR except immunofixation studies remained positive.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frits van Rhee, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577512
- Sponsor's protocol ID
- 2006-32
- Status last verified
- Oct 2017
- First submitted
- 18 Dec 2007
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2006-32: Phase II Study of Rapidly Recycled High Dose DTPACE (HD-DTPACE) for Untreated or Previously Treated, High-Risk Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT00577512
- Acronym / sponsor ID
- 2006-32
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 13 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done in an attempt to improve the remission rate and the survival time for subjects with high-risk myeloma. It is hoped that by giving higher doses of commonly used chemotherapy drugs and by giving courses closer together (before the myeloma comes back or gets worse), subjects in this study will have better outcomes.
Detailed description
This study has the following goals:
- To find out how many subjects treated with high dose DTPACE (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide. (HD DTPACE) on this protocol will have a complete response or near complete response that lasts for 6 months or longer.
- In subjects achieving a response, to find out how long the response will last.
- To learn more about the side effects of this treatment.
Up to 75 subjects, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at the University of Arkansas for Medical Sciences (UAMS) only.
The treatment in this study is divided into 3 parts
- High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored.
- High dose DTPACE and stem cell re-infusion.
- Velcade, Thalidomide, Dexamethasone (sometimes known as VTD) Maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD DTPACE | Experimental | Drug: DTPACEDTPACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with multiple myeloma, treated or untreated, with the presence of one or more of the high risk features as defined below.
- PROLIFERATION signature, MMSET/FGFR3, c-MAF/MAF-B gene groups or
- High risk score based on University of Arkansas Myeloma Institute for Research and Therapy (MIRT) 70 gene model.
Key exclusion criteria (8 listed)
- Fever or active infection requiring intravenous antibiotics within 72 hours from baseline.
- Liver function abnormalities with total bilirubin more than twice the upper limit of normal or aspartate amino transferase (AST)/alanine amino trasferase (ALT) more than three times the upper limit of normal.
- Severe renal dysfunction, defined as a creatinine > 3mg/dl or a creatinine clearance of <30ml/min.
- Platelet count < 30,000/mm3, or absolute neutrophil count (ANC) < 1,000/μl.
- Clinically significant hepatic dysfunction as noted by direct bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
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 |
|---|---|---|
| DTPACE* Dexamethasone 200 mg Intravenous Infusion "Piggy-Back" (IVPB) Days 1-7 * Thalidomide 200 mg by mouth (PO) Days 1-7 * Cisplatin 15mg/m2 Days 1-4 (modify for renal insufficiency) * Adriamycin 15 mg/m2 Days 1-4 * Cyclophosphamide 600 mg/m2 Days 1-4 * Etoposide 60 mg/m2 Days 1-4 | Drug | HD DTPACE |
Primary outcome
Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.
Time frame: 12 months
Complete Response (CR) defined as all of the following for a minimum of 2 months: a) absence of urine and serum M-components by immunofixation; b) bone marrow should be adequately cellular (>20%); c) normal serum calcium; d) no new bone lesions or enlargement of existing lesions. Near Complete Response included all elements of CR except immunofixation studies remained positive.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frits van Rhee, MD, PhD principal investigator
University of Arkansas
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 DTPACE in people with Multiple Myeloma, run by University of Arkansas 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 15 inclusion and 8 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 20 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 13 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer. (time frame: 12 months). 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 20 Nov 2017.