Clinical trial · Interventional
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial
NCT00335348CI-TRIAL-00008839completedPhase 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)
This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade. The second aim of this study is to see whether treating patients with relapsed multiple myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib and Dexamethasone
- interventionNames
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease.
- timeFrame
- 2 years
- measure
- Overall survival, defined as the time from commencement of treatment to the date of death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or \*third line therapy because of PD, defined as a 25% increase in M-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium \>11.5 mg/dL), or relapse from CR.\*Patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies. * Patient is of a legally consenting age, as defined by local regulations. * Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. * Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. * Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male patient agrees to use an acceptable method for contraception for the duration of the study. * Patient has measurable disease * Patient has a Karnofsky performance status ≥60%. * Patient has a life-expectancy \>3 months. Exclusion Criteria: * Primary Dexamethasone resistance * Prior therapy with Bortezomib * Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol * Neuropathy \> Grade 2 with pain by NCI-CTCAE criteria
References
Publications (1)
- DERIVEDHarrison SJ, Quach H, Link E, Feng H, Dean J, Copeman M, Van De Velde H, Schwarer A, Baker B, Spencer A, Catalano J, Campbell P, Augustson B, Romeril K, Prince HM. The addition of dexamethasone to bortezomib for patients with relapsed multiple myeloma improves outcome but ongoing maintenance therapy has minimal benefit. Am J Hematol. 2015 May;90(5):E86-91. doi: 10.1002/ajh.23967. Epub 2015 Feb 27. PMID 25651830