Waldenstrom MacroglobulinemiaPhase 2NCT00107614
DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients
A Phase 2 study testing DT PACE + Rituxan in people with Waldenstrom Macroglobulinemia, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia
- What is being tested?
- DT PACE + Rituxan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2008
- 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 must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection.
- Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above
- All necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration.
- Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
- Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
- Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% 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.
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- Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose.
- Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl.
- Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: *Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose.
- 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 due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as PO2 greater than 70.
Who cannot join
- 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.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205
About this study
Official title: UARK 2002-10, A Phase II Study of DT PACE Induction, Followed by Tandem Autologous Transplant and Maintenance Therapy for Patients With Advanced and/or Symptomatic Waldenstrom's Macroglobulinemia
The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants.
Read the detailed description
Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only.
Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide.
- Conditions
- Waldenstrom Macroglobulinemia
- Being tested
- DT PACE + Rituxan
- Keywords
- Waldenstrom
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT PACE + RituxanDrug
INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with < 50% response to induction) OR MEL-DT PACE (Patients with > 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year
| Study group | Role | What they receive |
|---|---|---|
| DT PACE/auto transplant/maint therapy | Experimental | Not described Receives: Drug: DT PACE + Rituxan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)
To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startNov 2002
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: Terminated due to poor accrual.
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 Waldenstrom MacroglobulinemiaStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Barlogie, MD, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107614
- Sponsor's protocol ID
- UARK 2002-10
- Status last verified
- Aug 2011
- First submitted
- 5 Apr 2005
- Last updated
- 26 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2002-10, A Phase II Study of DT PACE Induction, Followed by Tandem Autologous Transplant and Maintenance Therapy for Patients With Advanced and/or Symptomatic Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00107614
- Acronym / sponsor ID
- UARK 2002-10
- Conditions
- Waldenstrom Macroglobulinemia
- Keywords
- Waldenstrom
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor accrual.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Posted 15 Jul 2011
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 what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants.
Detailed description
Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only.
Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DT PACE/auto transplant/maint therapy | Experimental | Drug: DT PACE + Rituxan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection.
- Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above
- All necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration.
- Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
- Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
Key exclusion criteria (3 listed)
- 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.
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
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 |
|---|---|---|
| DT PACE + RituxanINDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with < 50% response to induction) OR MEL-DT PACE (Patients with > 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year | Drug | DT PACE/auto transplant/maint therapy |
Primary outcome
Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)
Time frame: 3 years
To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Multiple MyelomaLink provided by the sponsor.
Related trials for Waldenstrom Macroglobulinemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
Waldenstrom Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
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.
Bart Barlogie, 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 DT PACE + Rituxan in people with Waldenstrom Macroglobulinemia, 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 10 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: stopped early, as of the sponsor's last update on 26 Aug 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?
Yes. Results are posted in the registry (first posted 15 Jul 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?
Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT) (time frame: 3 years). 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 26 Aug 2011.