Phase 3
Completed N=498
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT02136134 ↗Enrolled (actual)
498
Serious AEs
39.2%
Results posted
Feb 2017
Primary outcomePrimary: Progression-free Survival (PFS) — 7.16; NA months
◆ Published Evidence
Highly cited
120citations · ~40 / year
Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial.
Summary
The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.
Linked Publications (5)
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Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial.
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Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA.
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Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX.
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Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.
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Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
7.16; NA | — |
| SECONDARY Time to Disease Progression (TTP) |
7.29; NA | — |
| SECONDARY Percentage of Participants With a Very Good Partial Response (VGPR) or Better |
29.1; 59.2 | — |
| SECONDARY Overall Response Rate (ORR) |
63.2; 82.9 | — |
| SECONDARY Percentage of Participants With Negative Minimal Residual Disease (MRD) |
2.8; 13.5 | — |
| SECONDARY Overall Survival (OS) |
38.51; 49.58 | — |
Eligibility Criteria
Inclusion Criteria
- Must have had documented multiple myeloma
- Must have received at least 1 prior line of therapy for multiple myeloma
- Must have had documented evidence of progressive disease as defined based on Investigator's determination of response of International Myeloma Working Group (IMWG) criteria on or after their last regimen
- Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
- Must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen in the past
Exclusion Criteria
- Has received daratumumab or other anti-CD38 therapies previously
- Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
- Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM).
- Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
- Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures
Data sourced from ClinicalTrials.gov (NCT02136134) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.