Multiple MyelomaPhase 2NCT00113932
UARK 2003-41: A Study of High-Dose Density Therapy in Patients With Multiple Myeloma
A Phase 2 study testing High-Dose Density Therapy in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past. 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?
- High-Dose Density Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jul 2010
- 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
- Patients with symptomatic multiple myeloma, previously treated or untreated.
- Patients previously untreated must not be eligible for UARK 2003-33.
- Karnofsky performance score > 60%, unless due to MM
- Patients must be <75 years of age at the time of registration
- Patient must not have had a prior auto- or allotransplant
- Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
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- Negative serology for HIV.
- Baseline studies within 60 days prior to registration; 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, 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 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 LVEF must be repeated.
Who cannot join
- Uncontrolled infection as defined in protocol section 5.1.11
- Liver function abnormalities with total bilirubin more than twice the upper limit of normal or AST or 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
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria
- Platelet count < 100,000/mm3, or ANC < 1,000/μl
- POEMS Syndrome
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- 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
- Myocardial infarction within the last 6 months
- Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias
- 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
- Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy [β-HCG] test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each dose of study drug
- Breast-feeding women may not participate
- 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: UARK 2003-41: A Phase II Study of High-Dose Density Therapy With Tandem Autologous Transplants for Patients With Multiple Myeloma
The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.
Read the detailed description
This study will evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.
- Conditions
- Multiple Myeloma
- Being tested
- High-Dose Density Therapy
- Keywords
- Myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Density TherapyProcedure or surgery
Dexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, \& every 2 weeks until HB >12 gm/dl***; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount <30,000/μl
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.
Measured: seven months
Secondary outcomes (1)
To evaluate the ability of pegfilgrastim to mobilize stem cells when administered following DTPACE in MM patients with active disease, compared to historical controls mobilized with DTPACE and either GM-CSF or G-CSF.
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startDec 2003
- Primary completionFeb 2009
- Study completionJul 2010
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 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, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113932
- Sponsor's protocol ID
- UARK 2003-41
- Status last verified
- Sep 2011
- First submitted
- 10 Jun 2005
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2003-41: A Phase II Study of High-Dose Density Therapy With Tandem Autologous Transplants for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00113932
- Acronym / sponsor ID
- UARK 2003-41
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Jun 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.
The purpose of this study is to find out if treating multiple myeloma (MM) patients with more intense chemotherapy and autologous transplant (high dose density therapy) early in the disease course will result in better treatment outcomes compared to patients treated in the past.
Detailed description
This study will evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (9 listed)
- Patients with symptomatic multiple myeloma, previously treated or untreated.
- Patients previously untreated must not be eligible for UARK 2003-33.
- Karnofsky performance score > 60%, unless due to MM
- Patients must be <75 years of age at the time of registration
- Patient must not have had a prior auto- or allotransplant
Key exclusion criteria (14 listed)
- Uncontrolled infection as defined in protocol section 5.1.11
- Liver function abnormalities with total bilirubin more than twice the upper limit of normal or AST or 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
- Significant neurotoxicity, defined as grade > 2 neurotoxicity per NCI Common Toxicity Criteria
- Platelet count < 100,000/mm3, or ANC < 1,000/μl
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 |
|---|---|---|
| High-Dose Density TherapyDexamethasone 40mg po 1-4, Thalidomide 200 mg po 1-6hrs then daily after transplant; Cisplatin* 10 mg/m2 Continuous infusion 1-4;Adriamycin 10 mg/m2 Continuous infusion 1-4;Cyclophosphamide 400 mg/m2 Continuous infusion 1-4; Etoposide 40 mg/m2 Continuous infusion 1-4; Pegfilgrastim 6 mg subcutaneously 6 and 13; Darbepoetin 200μg subcutaneously Between -6 to-1 +12, \& every 2 weeks until HB >12 gm/dl***; Lovenox (or other LMWH) 40 mg subcutaneously Daily until Pltcount <30,000/μl | Procedure or surgery | – |
Primary outcome
To evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls.
Time frame: seven months
1 secondary outcome
To evaluate the ability of pegfilgrastim to mobilize stem cells when administered following DTPACE in MM patients with active disease, compared to historical controls mobilized with DTPACE and either GM-CSF or G-CSF.
Time frame: annually
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 2 Sep 2011.
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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
UAMS
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 High-Dose Density Therapy 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 9 inclusion and 14 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 2 Sep 2011. 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?
To evaluate whether high-dose density treatment during the initial seven months, including tandem transplants within six months after starting therapy, results in superior event-free and overall survival rates as compared to historical controls. (time frame: seven 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 2 Sep 2011.