Clinical trial · Interventional
A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients
A Phase II Study to Assess the Safety and Efficacy of DBd Combination Therapy (DOXIL/CAELYX) [Doxorubicin HCL Liposome Injection], VELCADE [Bortezomib] and Dexamethasone) for Previously Untreated Multiple Myeloma Patients
NCT00561743CI-TRIAL-00005037completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether doxorubicin HCL liposome injection, bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of action.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary endpoint was complete response (CR) and near complete response rate (nCR) post induction therapy (i.e. 4 cycles of therapy). Each cycle consisted of 21 days.
Secondary outcomes (1)
- measure
- The secondary endpoints included time to best response, assessment of peripheral blood stem cells harvesting ( 3 weeks post cycle 4 day 21) and engraftment (within 4 weeks of mobilization), CR post-engraftment, QoL and safety (every cycle).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients with newly diagnosed multiple myeloma (MM) requiring therapy for whom stem cell transplantation is considered appropriate * Normal left ventricular ejection fraction * Able to give voluntary written informed consent * Female patients agree to use acceptable method for contraception Exclusion Criteria: * Diagnosis of smoldering multiple myeloma (asymptomatic MM with absence of lytic bone lesions) * Renal insufficiency related to the monoclonal protein * Diagnosis of Waldenström's disease * Previous treatment for MM (excepting emergency use of a short course dexamethasone, radiation received \> 30 days before study enrolment, plasmapheresis for treatment of clinically significant hyperviscosity syndrome \> 30 days before trial enrolment) * Major surgery within 30 days before entry * Peripheral neuropathy or neuropathic pain Grade 2 or higher within 14 days of trial enrolment * Uncontrolled or severe cardiovascular disease (including myocardial infarction within 6 months prior to enrollment * NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, cardiac amyloidosis, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities) * Other malignancy within the past 5 years prior to enrolment (except for non-active basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or Stage 1 carcinoma of the cervix * Known HIV seropositivity or active hepatitis A, B, or C infection * Use of any investigational drug within 30 days prior to enrolment in the trial * Medical or psychiatric condition that could interfere with trial participation * History of hypersensitivity or allergic reaction attributable to compounds containing boron, mannitol or doxorubicin.
References
Publications (0)
Data not yet available
No reference posted for this study.