A Phase 2 interventional study of Bortezomib in Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma, sponsored by Seoul National University Hospital. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment
Among 29 studies testing bortezomib in Waldenstrom Macroglobulinemia — 1 open to participants now, 3 under way, none of them phase 3. Bortezomib · Waldenstrom Macroglobulinemia.
Among the 29 studies testing bortezomib in Waldenstrom Macroglobulinemia, this one is the 25th largest by planned enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2016, is one of 18 in phase 2, and was the 27th registered.
524 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
Browse Waldenstrom Macroglobulinemia studies →1 of the 29 studies testing bortezomib in Waldenstrom Macroglobulinemia is open now, in 1 country. Recruiting first, the newest first:
Kosin University Gospel Hospital · Sites in Korea, Republic of
By country, each count listing its studies:
Bortezomib: first FDA approval 2003 (VELCADE), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 48 Waldenstrom Macroglobulinemia studies recruiting now, 44 (92%) set no upper age limit and 1 (2%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 20 · Phase 3 1 · Phase 4 1
First in 1999; this study’s year is marked. 2 started in 2016.
This study's planned enrollment of 15 is below the median of 39 across 429 interventional studies indexed under Waldenstrom Macroglobulinemia.
Median enrollment 41 across the 28 interventional studies. Of the 24 that completed or were terminated, 8 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 29 has an industry lead sponsor. The 10 most frequent:
Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Seoul National University Hospital has 3 studies filed under Waldenstrom Macroglobulinemia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 29 studies testing bortezomib in Waldenstrom Macroglobulinemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is a phase 2, single-arm, open-label, multi-institutional trial to evaluate the efficacy of combination therapy of bortezomib, thalidomide, and dexamethasone in patients with newly diagnosed Waldenstrom's macroglobulinemia and lymphoplasmacytic lymphoma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous bortezomib 1.3mg/m2 on days 1, 4, 8, and 11 (every 4 weeks, up to 6 cycles) Oral thalidomide 50mg daily on days 1-28 (every 4 weeks, up to 6 cycles) Intravenous or oral dexamethasone 40mg on days 1-4 (every 4 weeks, up to 6 cycles)
Drug: Bortezomib
Six 4-week cycles
Also known as: Thalidomide, Dexamethasone
Overall response rate
Overall response rate as per Lugano criteria
Time frame: at 3 years
Progression-free survival
Time from enrollment to disease progression or death from any cause
Time frame: at 3 years
Overall survival
Time from enrollment to death from any cause
Time frame: at 3 years
Plan to share: Yes — IPD regarding participant demographics, study treatment, response, survival, and adverse events will be shared after publishment of the study results.
Time frame: IPD will be shared after the publication of the study results without time limit.
Access criteria: IPD will be shared only for the research purpose.
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Dec 2020, 49 months after the start.
Of 55 non-industry phase 2 interventional studies under Waldenstrom Macroglobulinemia, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 103. This study's planned 49 months is below that.
Counting every sponsor, half of 66 studies reached it within 64 months; a quarter within 45 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bortezomib
Waldenstrom Macroglobulinemia →
Seoul National University Hospital →