NCT00378105Active, not recruitingPhase 1/2
Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to determine the safety and efficacy of the bortezomib, lenalidomide and dexamethasone combination in patients with newly diagnosed multiple myeloma. We are looking for the highest dose of the combination that can be given safely and see how well it works as a combination in newly diagnosed patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 18 Sept 2006
- Start date
- Sept 2006
- Primary completion date
- Jul 2009
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Multiple myeloma
- NCT number
- NCT00378105
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 68
- From Sept 2006 to the primary completion date, Jul 2009
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment
- Concomitant therapy medications that include corticosteroids
- Myocardial infarction within 6 months prior to enrollment according to NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Known intolerance to steroid therapy
Other illness
- Clinically relevant active infection or serious co-morbid medical conditions
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer
- Serious medical or psychiatric illness likely to interfere with participation in study
- Uncontrolled diabetes mellitus
- Hypersensitivity to acyclovir or similar anti-viral drug
- POEMS syndrome
- Known HIV infection
- Known active hepatitis B or C viral infection
Lab values
- Renal insufficiency (serum creatinine \>2.5 mg/dL)
- Evidence of mucosal or internal bleeding and/or platelet refractory
- ANC (absolute neutrophil count)\< 1000 cells/mm3
- Hemoglobin \< 8.0 g/dL
- AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than or equal to 2 x ULN (upper limit of normal)
Other
- Pregnant or breast-feeding
Who the study is looking for
- Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new International Myeloma Foundation 2003 Diagnostic Criteria
- Must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma
- Negative serum or urine pregnancy test
- Age 18 years or older
- Karnofsky performance status of greater or equal to 60
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.