Clinical trial · Interventional
Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma
An Open-Label Phase I Study of the Safety and Efficacy of Bortezomib in Combination With CC-5013 in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma
NCT00153933CI-TRIAL-00020648completedPhase 1ClinicalTrials.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 if this study is to evaluate the side effects of the combination of bortezomib and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.
Conditions
Conditions (3)
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 |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| CC-5013 | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CC-5013 in combination with bortezomib
- description
- Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.
- interventionNames
- Drug: Bortezomib
- Drug: CC-5013
Primary outcomes (1)
- measure
- To evaluate the safety of bortezomib when given in combination with CC-5013 in subjects with relapsed and relapsed/refractory multiple myeloma, to identify the MTD as well as a RP2D.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To evaluate the response of the combination of bortezomib and CC-5013
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions. * Must have relapsed or relapsed/refractory disease * 18 years of age or older * All baseline studies must be performed within 21 days of enrollment. * ECOG performance status of 0 to 2 Exclusion Criteria: * Renal insufficiency (serum creatinine levels \> 2mg/dL) * Concomitant therapy medications that include corticosteroids * Peripheral neuropathy of Grade 3 or greater or painful Grade 2 * Evidence of mucosal or internal bleeding and/or platelet refractory * ANC \< 1000 cells/mm3 * Hemoglobin \< 8.0 g/dL * AST (SGOT and ALT) \> 2 x ULN * Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol * Known hypersensitivity to thalidomide or the development of erythema nodosum * Active infection or serious co-morbid medical condition * Pregnant or breast-feeding women * Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.