Clinical trial · Interventional
Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma
A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade When Added to Adriamycin-Dexamethasone Treatment Versus Vincristine-Adriamycin-Dexamethasone Standard Treatment in Subjects With Multiple Myeloma Who Are Refractory to or Have Relapsed After Primary Therapy for Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): TRIAL STOPPED due to a change in standard of care and the required patient numbers could no longer be achieved
Summary
Brief summary (as posted)
The purpose of this research study is to test the safety and effectiveness of replacing vincristine with a drug called bortezomib (also known as "Velcade"or PS341) in the standard therapy vincristine, doxorubicin (not limited to, but formerly referred to under the tradename Adriamycin) and dexamethasone (VAD) in patients with multiple myeloma. Multiple Myeloma is the second most common cancer of the blood. Bortezomib is the first approved cancer treatment in a new class of medicines called proteasome inhibitors. It disrupts the cell cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells. The treatment will be used as second line treatment, which means either the disease has returned after a period of improvement (relapse) or the disease did not respond to the initial treatment (refractory). Patients will receive either bortezomib (PS341), doxorubicin (Adriamycin) and dexamethasone (PAD) or the VAD standard therapy.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adriamycin | Drug | — | UNRESOLVED |
| bortezomib | Drug | Bortezomib | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- VAD Treatment
- description
- vincristine in combination with adriamycin and dexamethasone
- interventionNames
- Drug: adriamycin
- Drug: dexamethasone
- Drug: vincristine
- type
- EXPERIMENTAL
- label
- PAD Treatment
- description
- bortezomib in combination with adriamycin and dexamethasone
- interventionNames
- Drug: adriamycin
- Drug: bortezomib
- Drug: dexamethasone
Primary outcomes (2)
- measure
- Best Confirmed Disease Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy * measurable secretory multiple myeloma based on defined criteria * Karnofsky performance status of \>or = 60% * fulfils defined laboratory requirements within 14 days before baseline * if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time * if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time. Exclusion Criteria: * More than one previous line of therapy for multiple myeloma * use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial * known allergy or hypersensitivity to bortezomib, boron or mannitol * peripheral neuropathy or neuropathic pain of grade 2 or higher * myocardial infarction within 6 months of enrollment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
References
Publications (0)
Data not yet available