Multiple MyelomaPhase 2NCT01055301
S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing bortezomib, cisplatin and cyclophosphamide in people with Multiple Myeloma and Plasma Cell Myeloma, run by SWOG Cancer Research Network at 21 sites in United States.
Trial summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Myeloma
- What is being tested?
- bortezomib, cisplatin and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2011to Jul 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Newly diagnosed active multiple myeloma (MM)
- Measurable disease
- Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or multiple (> 3) focal plasmacytomas on skeletal survey and/or MRI
PATIENT CHARACTERISTICS:
- Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone pain)
- ANC ≥ 1,500/mm^3*
- Platelet count ≥ 150,000/mm^3*
- Serum creatinine clearance of ≥ 60 mL/min
- Patients with creatinine clearance of < 60 mL/min receive a lower dose of melphalan
- No patients receiving or planning to receive dialysis
- Total bilirubin ≤ 1.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be fully aware of the teratogenic potential of thalidomide
- Must be willing to comply with the FDA-mandated S.T.E.P.S. program
- Ejection fraction > 40% as measured by MUGA scan or two-dimensional ECHO
- No peripheral neuropathy ≥ grade 2 per CTCAE v. 4.0
- No known hypersensitivity to bortezomib, boron, or mannitol
- No uncontrolled diabetes defined as fasting glucose level > 200 mg/dL on at least more than two occasions or more that two serum random blood levels > 300 mg/dL despite adequate treatment
- Patients with a history of diabetes mellitus requiring treatment should be on a stable regimen and have their blood glucose closely monitored
- No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment within the past year NOTE: *Unless myeloma-related marrow infiltration is documented, defined as ≥ 30% marrow cellularity with 50% of the cells being malignant plasma cells.
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior chemotherapy or radiotherapy
- No more than 1 prior course of chemotherapy for MM
- Prior chemotherapy must not have included melphalan
- No prior radiotherapy to large area of the pelvis (more than half of the pelvis)
- Prior radiotherapy for symptomatic localized bone lesions or impending cord compression allowed
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, 71315-3198
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Hematology-Oncology Clinic
Baton Rouge, Louisiana, 70809
St. Joseph Cancer Center
Bellingham, Washington, 98225
Olympic Hematology and Oncology
Bremerton, Washington, 98310
Highline Medical Center Cancer Center
Burien, Washington, 98166
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216
Columbia Basin Hematology
Kennewick, Washington, 99336
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, 98274
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, 98370
Harborview Medical Center
Seattle, Washington, 98104
Minor and James Medical, PLLC
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Group Health Central Hospital
Seattle, Washington, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Evergreen Hematology and Oncology, PS
Spokane, Washington, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801-2028
About this study
Official title: S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma.
PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- To assess progression-free survival (PFS) at 3 years in patients with newly diagnosed multiple myeloma (MM) treated with modified Total Therapy 3 (TT3).
Secondary
- To estimate the frequency and severity of toxicities associated with this treatment strategy in these patients.
Correlative
- To perform gene expression profiling on CD138+ purified MM cells and unseparated bone marrow biopsy samples to identify the bone marrow micro-environment signature.
- To determine whether the 70-gene model, developed in the Arkansas Total Therapy 2 (TT2) and validated in the Arkansas TT3 study, also applies to the cooperative group setting.
- Determine whether the novel finding in TT3 of the prognostically favorable suppression of a micro-environment-associated gene, MAG1, also applies to the cooperative group setting.
- Once in complete remission, determine whether the MAG signatures can return to a normal individual's signature as an indication of profound tumor cytoreduction with durable PFS.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11; oral thalidomide and oral dexamethasone on days 1-4; and cisplatin IV continuously, doxorubicin hydrochloride IV continuously, cyclophosphamide IV continuously, and etoposide IV continuously on days 1-4.
- Peripheral blood stem cell (PBSC) collection: Beginning within 2 months after completion of induction therapy, patients undergo PBSC collection until an adequate number of cells are collected. Patients with persistent disease after completion of induction therapy proceed to bridging therapy after adequate stem cells are collected. Patients not requiring bridging therapy proceed directly to transplant.
- Bridging therapy: Patients receive oral thalidomide on days 1-21 and oral dexamethasone on days 1, 8, and 15. Treatment repeats every 21 days for 1-2 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to transplant.
- First autologous PBSC transplantation: Beginning within 6 weeks to 3 months after completion of induction therapy (or ≥ 1 week after completion of bridging therapy), patients receive bortezomib IV on days -4 and -1 and melphalan IV, oral thalidomide, and oral dexamethasone on days -4 to -1. Patients undergo autologous PBSC transplantation on day 0.
- Inter-transplant bridging therapy: Patients with persistent disease after completion of the first autologous PBSC transplant receive bridging therapy as above and then proceed to the second transplant. Patients not requiring bridging therapy proceed directly to the second transplant.
- Second autologous PBSC transplantation: Beginning within 6 months after the first PBSC transplant, patients receive bortezomib, melphalan, thalidomide, and dexamethasone and undergo autologous PBSC as in the first transplant. Patients who skip the second transplant (due to medical or insurance reasons or refusal) proceed to consolidation therapy.
- Consolidation therapy: Beginning within 6 months after the last transplant, patients receive bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, and etoposide as in induction therapy.
- Post-consolidation bridging therapy: Patients with persistent disease after completion of consolidation therapy receive oral thalidomide on days 1-21 and oral dexamethasone on days 1, 8, and 15. Patients then proceed to maintenance therapy. Patients not requiring bridging therapy proceed directly to maintenance therapy.
- Maintenance therapy: Beginning within 4 months after completion of consolidation therapy or post-consolidation bridging therapy, patients receive bortezomib IV and oral dexamethasone on days 1, 8, 15, and 22 and oral lenalidomide on days 1-20. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples may be collected at baseline and periodically during study for gene expression profile analysis.
After completion of study therapy, patients are followed up periodically for up to 7 years.
- Conditions
- Multiple Myeloma, Plasma Cell Myeloma
- Being tested
- bortezomib, cisplatin, cyclophosphamide, dexamethasone, doxorubicin hydrochloride
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Also called bort
cisplatinDrug
cyclophosphamideDrug
dexamethasoneDrug
etoposideDrug
lenalidomideDrug
melphalanDrug
thalidomideDrug
gene expression analysisGenetic
microarray analysisGenetic
laboratory biomarker analysisOther
autologous-autologous tandem hematopoietic stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Ind (1cycle):
bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d \& dex 20mg/d PO; cisplatin \& dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn.
PBSC Coll: at recovery per local standard
Bridging (before/between trans/after Cons):
thal 50mg/d D1-21 \& dex 20mg D1,8,15 PO
Tandem Trans (x2):
bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d \& dex 40mg/d PO PBSC >/=200x10^6 cells
Cons (1cycle):
same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox
Maint(</= 3 yrs):
D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20 Receives: Drug: bortezomib; Drug: cisplatin; Drug: cyclophosphamide; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: lenalidomide; Drug: melphalan; Drug: thalidomide; Genetic: gene expression analysis; Genetic: microarray analysis; Other: laboratory biomarker analysis; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 3 years
Measured: 3 years
Secondary outcomes (3)
Overall survival
Measured: 3 years
Frequency and severity of toxicities
Measured: 3 years
Gene expression profiling analysis of CD138+ purified plasma cells
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 posted25 Jan 2010 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: lack of accrual
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 SWOG Cancer Research NetworkThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Muneer H. Abidi, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055301
- Sponsor's protocol ID
- S0833
- Other IDs
- S0833, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 22 Jan 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S0833, Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients With Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged ≤ 65 Years
- ClinicalTrials.gov ID
- NCT01055301
- Acronym / sponsor ID
- S0833
- Conditions
- Multiple Myeloma, Plasma Cell Myeloma
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Jan 2010 (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.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma.
PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- To assess progression-free survival (PFS) at 3 years in patients with newly diagnosed multiple myeloma (MM) treated with modified Total Therapy 3 (TT3).
Secondary
- To estimate the frequency and severity of toxicities associated with this treatment strategy in these patients.
Correlative
- To perform gene expression profiling on CD138+ purified MM cells and unseparated bone marrow biopsy samples to identify the bone marrow micro-environment signature.
- To determine whether the 70-gene model, developed in the Arkansas Total Therapy 2 (TT2) and validated in the Arkansas TT3 study, also applies to the cooperative group setting.
- Determine whether the novel finding in TT3 of the prognostically favorable suppression of a micro-environment-associated gene, MAG1, also applies to the cooperative group setting.
- Once in complete remission, determine whether the MAG signatures can return to a normal individual's signature as an indication of profound tumor cytoreduction with durable PFS.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11; oral thalidomide and oral dexamethasone on days 1-4; and cisplatin IV continuously, doxorubicin hydrochloride IV continuously, cyclophosphamide IV continuously, and etoposide IV continuously on days 1-4.
- Peripheral blood stem cell (PBSC) collection: Beginning within 2 months after completion of induction therapy, patients undergo PBSC collection until an adequate number of cells are collected. Patients with persistent disease after completion of induction therapy proceed to bridging therapy after adequate stem cells are collected. Patients not requiring bridging therapy proceed directly to transplant.
- Bridging therapy: Patients receive oral thalidomide on days 1-21 and oral dexamethasone on days 1, 8, and 15. Treatment repeats every 21 days for 1-2 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to transplant.
- First autologous PBSC transplantation: Beginning within 6 weeks to 3 months after completion of induction therapy (or ≥ 1 week after completion of bridging therapy), patients receive bortezomib IV on days -4 and -1 and melphalan IV, oral thalidomide, and oral dexamethasone on days -4 to -1. Patients undergo autologous PBSC transplantation on day 0.
- Inter-transplant bridging therapy: Patients with persistent disease after completion of the first autologous PBSC transplant receive bridging therapy as above and then proceed to the second transplant. Patients not requiring bridging therapy proceed directly to the second transplant.
- Second autologous PBSC transplantation: Beginning within 6 months after the first PBSC transplant, patients receive bortezomib, melphalan, thalidomide, and dexamethasone and undergo autologous PBSC as in the first transplant. Patients who skip the second transplant (due to medical or insurance reasons or refusal) proceed to consolidation therapy.
- Consolidation therapy: Beginning within 6 months after the last transplant, patients receive bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, and etoposide as in induction therapy.
- Post-consolidation bridging therapy: Patients with persistent disease after completion of consolidation therapy receive oral thalidomide on days 1-21 and oral dexamethasone on days 1, 8, and 15. Patients then proceed to maintenance therapy. Patients not requiring bridging therapy proceed directly to maintenance therapy.
- Maintenance therapy: Beginning within 4 months after completion of consolidation therapy or post-consolidation bridging therapy, patients receive bortezomib IV and oral dexamethasone on days 1, 8, 15, and 22 and oral lenalidomide on days 1-20. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples may be collected at baseline and periodically during study for gene expression profile analysis.
After completion of study therapy, patients are followed up periodically for up to 7 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: bortezomib, Drug: cisplatin, Drug: cyclophosphamide, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: lenalidomide, Drug: melphalan, Drug: thalidomide, Genetic: gene expression analysis, Genetic: microarray analysis, Other: laboratory biomarker analysis, Procedure: autologous-autologous tandem hematopoietic stem cell transplantationInd (1cycle): bort 1mg/m2 IV/SQ D1,4,8,11 D1-4: thalid 200mg/d \& dex 20mg/d PO; cisplatin \& dox 10mg/m2/d, cyclophos 400mg/m2/d, etoposide 40mg/m2/d contIV; enoxaparin 40mg/d SQ prn. PBSC Coll: at recovery per local standard Bridging (before/between trans/after Cons): thal 50mg/d D1-21 \& dex 20mg D1,8,15 PO Tandem Trans (x2): bort 1mg/m2 IV/SQ D-4,-1 D-4to-1: mel 50 mg/m2 IV, thal 200mg/d \& dex 40mg/d PO PBSC >/=200x10^6 cells Cons (1cycle): same as Ind except cis/dox 7.5mg/m2/d, cyclo 300mg/m2/d, no enox Maint(</= 3 yrs): D1,8,15,22:bort 1mg/m2 IV/SQ, dex 20mg/d PO; len 20mg/d PO D1-20 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bortezomibAlso: bort | Drug | treatment |
| cisplatin | Drug | treatment |
| cyclophosphamide | Drug | treatment |
| dexamethasone | Drug | treatment |
| doxorubicin hydrochloride | Drug | treatment |
| etoposide | Drug | treatment |
| lenalidomide | Drug | treatment |
| melphalan | Drug | treatment |
| thalidomide | Drug | treatment |
| gene expression analysis | Genetic | treatment |
| microarray analysis | Genetic | treatment |
| laboratory biomarker analysis | Other | treatment |
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure or surgery | treatment |
Primary outcome
Progression-free survival at 3 years
Time frame: 3 years
3 secondary outcomes
Overall survival
Time frame: 3 years
Frequency and severity of toxicities
Time frame: 3 years
Gene expression profiling analysis of CD138+ purified plasma cells
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Muneer H. Abidi, MD principal investigator
Barbara Ann Karmanos Cancer Institute
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, cisplatin and cyclophosphamide in people with Multiple Myeloma and Plasma Cell Myeloma, run by SWOG Cancer Research Network at 21 sites 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?
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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival at 3 years (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 6 Mar 2015.