← Back to Search

Proteasome Inhibitor

BLd Combination Therapy for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Paul Richardson, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up survival rate at 18 months
Awards & highlights

Study Summary

This trial is testing a new combination therapy for multiple myeloma. The goal is to find the highest dose of the combination that can be given safely, and to see how well it works in newly diagnosed patients.

Who is the study for?
This trial is for adults over 18 with newly diagnosed multiple myeloma who haven't had systemic therapy before. They should be relatively active (Karnofsky score ≥60) and not pregnant. Exclusions include serious illnesses, prior cancers (with some exceptions), renal insufficiency, low blood counts, liver enzyme abnormalities, certain heart conditions, uncontrolled diabetes or infections, known drug allergies and HIV.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a combination therapy using Bortezomib, Lenalidomide, and Dexamethasone in patients with new multiple myeloma. It aims to find the highest safe dose of this mix and how well it works together as an initial treatment.See study design
What are the potential side effects?
Possible side effects may include nerve damage (neuropathy), blood clots, bone marrow suppression leading to lower blood cell counts; increased risk of infections; digestive issues like constipation or diarrhea; muscle cramps; fatigue; skin rash; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not received any systemic therapy for my multiple myeloma.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with multiple myeloma.
Select...
I can care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pfs rate at 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pfs rate at 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate of the Drug Combination in This Patient Populations.
Secondary outcome measures
Estimated 18-month Overall Survival Rate
Estimated 18-month Progression Free Survival (PFS) Rate
Percentage of Patients Who Remained in Response for More Than 18 Months

Side effects data

From 2015 Phase 3 trial • 393 Patients • NCT00004228
100%
Leukocytes (total WBC)
100%
Hemoglobin (Hgb)
100%
Platelets
98%
Catheter-related infection
98%
Infection without neutropenia
98%
SGPT (ALT)
98%
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
97%
Febrile neutropenia
97%
SGOT (AST)
97%
Serum Creatinine
97%
Seizure(s)
95%
Pancreatitis
95%
Osteonecrosis (avascular necrosis)
95%
Renal failure
95%
Cardiac left ventricular function
95%
CNS cerebrovascular ischemia
95%
Bilirubin
92%
Cardiovascular/Arrhythmia
91%
Infection/Febrile Neutropenia
70%
Neutrophils/granulocytes (ANC/AGC)
45%
Transfusion: pRBCs
22%
Transfusion: Platelets
20%
Lymphopenia
20%
Hyperglycemia
14%
Nausea
14%
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
14%
Headache
13%
Hypokalemia
11%
Hypocalcemia
11%
Thrombosis/embolism
11%
Constipation
11%
Dehydration
11%
Diarrhea (without colostomy)
11%
Vomiting
11%
Anorexia
9%
Abdominal pain or cramping
9%
Pain
8%
Hypomagnesemia
8%
Hypophosphatemia
8%
Hyponatremia
8%
Weight gain
8%
Hypoalbuminemia
8%
Myalgia (muscle pain)
8%
Neuropathic pain
8%
Cough
6%
Hyperkalemia
6%
Mood alteration-depression
6%
Allergic reaction/hypersensitivity
6%
Hypertension
6%
Neuropathy - motor
5%
GGT
5%
Syncope (fainting)
5%
Earache (otalgia)
5%
Fibrinogen
5%
Fatigue (lethargy, malaise, asthenia)
5%
Alopecia
5%
Rash/desquamation
5%
Gastritis
5%
Gastrointestinal
5%
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
5%
Dizziness/lightheadedness
5%
Dyspnea (shortness of breath)
5%
Neuropathy - sensory
5%
Bone pain
5%
Amylase
5%
Arthralgia (joint pain)
3%
Arthritis
3%
Mood alteration-anxiety, agitation
3%
Hypermagnesemia
3%
Typhlitis (inflammation of cecum)
3%
Proteinuria
3%
Neurology
3%
Endocrine
3%
Seizure
3%
Hypotension
3%
Partial thromboplastin time (PTT)
3%
Coagulation
3%
Weight loss
3%
Colitis
3%
Hypernatremia
3%
Hypertriglyceridemia
3%
Hypoglycemia
3%
Insomnia
3%
Rectal or perirectal pain
3%
Renal/Genitourinary
3%
Edema
3%
Bicarbonate
3%
Allergic Rhinitis
3%
Hypoxia
3%
Fever
3%
Dermatology/Skin
3%
Dysuria
3%
Alkaline phosphatase
2%
Personality/behavioral
2%
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
2%
Mouth dryness
2%
Muscle weakness (not due to neuropathy)
2%
Prothrombin time (PT)
2%
Tremor
2%
Pneumonitis/pulmonary infiltrates
2%
Pneumothorax
2%
Hemolysis
2%
Melena/GI bleeding
2%
Autoimmune reaction
2%
Headache, Vomiting, Nausea, Pancytopenia, Fever
2%
N/V, Diplopia
2%
Allergy/Immunology
2%
Auditory/Hearing
2%
Palpitations
2%
Sinus tachycardia
2%
DIC (disseminated intravascular coagulation)
2%
Erythema multiforme
2%
SIADH (syndrome of inappropriate antidiuretic hormone)
2%
Dysphagia, esophagitis, odynophagia (painful swallowing)
2%
Fistula-intestinal
2%
Gastric ulcer
2%
Epistaxis
2%
Hematemesis
2%
Hepatic
2%
Infection with unknown ANC
2%
Hypercholesterolemia
2%
Ataxia (incoordination)
2%
Depressed level of consciousness
2%
Chest pain (non-cardiac and non-pleuritic)
2%
Urinary frequency/urgency
2%
Irregular menses
2%
Dry skin
2%
Wound-infectious
2%
Fistula-rectal/anal
2%
Infection/Febrile Neutropenia (sepsis)
2%
Vasovagal episode
2%
Hematuria (in the absence of vaginal bleeding)
2%
Vision-photophobia
2%
Pleural effusion (non-malignant)
2%
Pulmonary
2%
Tumor lysis syndrome
2%
Musculoskeletal
2%
Extrapyramidal/involuntary movement/restlessness
2%
Ileus
2%
Lipase
2%
Ocular/Visual
2%
Speech impairment
2%
Vision-blurred vision
2%
Vaginal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens
A2 (Disseminated, No CNS - CCG Mod BFM w/Intens
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment
A0 (Localized Disease Stg I/II) Modified CCG BFM

Trial Design

1Treatment groups
Experimental Treatment
Group I: lenalidomide, dexamethasone, bortezomib combinationExperimental Treatment3 Interventions
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Bortezomib
2005
Completed Phase 2
~1140
dexamethasone
1995
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,338 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,254 Patients Enrolled for Multiple Myeloma
Brigham and Women's HospitalOTHER
1,599 Previous Clinical Trials
11,462,446 Total Patients Enrolled
11 Trials studying Multiple Myeloma
442 Patients Enrolled for Multiple Myeloma
Beth Israel Deaconess Medical CenterOTHER
835 Previous Clinical Trials
13,006,462 Total Patients Enrolled
13 Trials studying Multiple Myeloma
1,062 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00378105 — Phase 1 & 2
Multiple Myeloma Research Study Groups: lenalidomide, dexamethasone, bortezomib combination
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT00378105 — Phase 1 & 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00378105 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide any details on past experiments involving dexamethasone?

"At the present moment, there are 733 clinical trials being conducted to evaluate dexamethasone. Of these studies, 168 are in their final stage of evaluation (Phase 3). While most of the experiments occur at a single location in Joliet, Illinois; 26098 other sites around the world are running research into this medication."

Answered by AI

Is this research endeavor currently open to new participants?

"As indicated by information posted on clinicaltrials.gov, this research trial is no longer recruiting participants. The study was initially announced in September of 2006 and the last update made to its page happened on March 29th 2022. Despite this particular project not being actively seeking new candidates right now, there are 1540 other trials which do require enrolment at present moment."

Answered by AI

What indications have been found to respond best to dexamethasone therapy?

"Dexamethasone can be used to treat a wide variety of afflictions, such as ophthalmia nervosa and sympathetic edema. This medication has also been approved for use in cases involving branch retinal vein occlusion and macular edema that have not responded to two prior chemotherapy regimens."

Answered by AI

What is the aggregate participation figure of this medical experiment?

"This clinical trial is no longer open for recruitment. Originally posted on September 1st 2006, the listing was last updated on March 29th 2022. However, there are currently 807 trials related to multiple myeloma and 733 related to dexamethasone searching for participants."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025