A Phase 1/2 interventional study of bortezomib in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-08-17.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1/2, Interventional, and Treatment
Among 271 studies testing bortezomib in Multiple Myeloma — 12 open to participants now, 40 under way, 14 of them phase 3. Bortezomib · Multiple Myeloma.
Among the 271 studies testing bortezomib in Multiple Myeloma, this one is the 172nd largest by enrollment of the 267 interventional ones that give a count, is one of 17 that started in 2004, is one of 35 in phase 1/2, and was the 10th registered.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
Browse Multiple Myeloma studies →12 of the 271 studies testing bortezomib in Multiple Myeloma are open now, in 10 countries. Recruiting first, the newest first:
Tanta University · Sites in Egypt
Canadian Myeloma Research Group · Sites in Canada
Peking University First Hospital · Sites in China
Stichting European Myeloma Network · Sites in Austria, Germany, Greece and 2 more countries
Memorial Sloan Kettering Cancer Center · Sites in United States
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 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 69 Years · 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.
271 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 76 · Phase 2 176 · Phase 3 46 · Phase 4 8
First in 1999; this study’s year is marked. 17 started in 2004.
This study's enrollment of 30 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Median enrollment 41 across the 267 interventional studies. Of the 194 that completed or were terminated, 94 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
61 of 271 have an industry lead sponsor. The 10 most frequent:
Jonsson Comprehensive Cancer Center is the lead sponsor of 398 studies on the registry; 66 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Jonsson Comprehensive Cancer Center has 9 studies filed under Multiple Myeloma — fewer than ten, so there is no comparison to draw.
9 of the studies testing bortezomib in Multiple Myeloma that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03729804Phase 3University of ChicagoCarfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA) | 2026-12-28 |
| NCT03319667Phase 3SanofiA Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant | 2027-04-05 |
| NCT05665140Phase 3University Hopsital Schleswig Holstein Campus LübeckExpression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients | 2027-08 |
| NCT00734877Phase 3University of ArkansasUARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma | 2027-09 |
| NCT02718833Massachusetts General HospitalA Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma | 2026-12 |
Among the 271 studies testing bortezomib in Multiple Myeloma, from their registry updates:
This tab as a report to print or save as PDF → With an account.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission.
PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: bortezomib
Progression-free Survival
Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (\~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.
Time frame: signed consent to progression or end of trial. Up to 5 years.
Overall Survival
Time frame: up to 5 years from time of consent
| Milestone | Bortezomib |
|---|---|
| Started | 30 |
| Completed | 17 |
| Not completed | 13 |
| Withdrew: Relapsed | 8 |
| Withdrew: Death | 3 |
| Withdrew: Withdrawal by subject | 2 |
Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (\~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.
| months | Bortezomib |
|---|---|
| Progression-free Survival | 29 (18 to 45) |
| months | Bortezomib |
|---|---|
| Overall Survival | 55 (16 to 86) |
Collected over Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bortezomib | — | 2/30 (6.7%) | 19/30 (63.3%) |
| Event | Bortezomib |
|---|---|
| Nausea/DehydrationGeneral disorders | 1/30 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | Bortezomib |
|---|---|
| FatigueGeneral disorders | 19/30 |
| PainGeneral disorders | 17/30 |
| NeuropathyGeneral disorders | 11/30 |
| PlateletsGeneral disorders | 10/30 |
| nausea/vomitingGeneral disorders | 9/30 |
| DiarrheaGastrointestinal disorders | 7/30 |
| Herpes Zoster ReactivationImmune system disorders | 7/30 |
| NeutrophilsGeneral disorders | 6/30 |
| CoughInfections and infestations | 4/30 |
| ConstipationGastrointestinal disorders | 3/30 |
| Age, Categorical(Participants) | Bortezomib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Bortezomib |
|---|---|
| Female | 16 |
| Male | 14 |
| Region of Enrollment(participants) | Bortezomib |
|---|---|
| United States | 30 |
The record gives a start of Jun 2004, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 3 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bortezomib
Jonsson Comprehensive Cancer Center →