Phase 2
Completed N=51
A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT00229203 ↗Enrolled (actual)
51
Serious AEs
61.4%
Results posted
Dec 2009
Primary outcomePrimary: Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response — 0; 0; 3; 11 percentage patients
Summary
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response |
0; 0; 3; 11; 7; 11 | — |
| SECONDARY Time to Progression (TTP) |
2.3; 4.2 | — |
| SECONDARY Progression Free Survival (PFS) |
2.3; 3.8 | — |
| SECONDARY Number of Patients With Overall Survival (OS) |
70; 76; 53; 61 | — |
Eligibility Criteria
Inclusion criteria
- Written informed consent obtained from the patient before starting any study-specific procedure. If any patient is unable to give consent, it may be obtained from the patient's legal representative if in accordance with local laws and regulations
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Life expectancy ≥ 3 months.
- Patient was previously diagnosed with MM based on standard criteria and currently requires treatment because MM relapses following a response to standard chemotherapy or high-dose chemotherapy, or MM is refractory (i.e., failure to achieve at least complete response (CR), partial response (PR) or stable disease (SD)) to their most recent chemotherapy.
- Patient has measurable disease, defined as follows:
- For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
- For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. Magnetic resonance imaging (MRI), Computerized Axial Tomography (CT-Scan)).
- Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 2.5 ULN in two different determinations performed with one week apart)
- Significant non-neoplastic liver disease (e.g. cirrhosis, active chronic hepatitis)
- Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months)
- Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- Treatment with any investigational product in the 30 days period before inclusion in the study or radiotherapy in the 4 weeks before inclusion in the study. Other previous treatments should have been completed 3 weeks before inclusion in the study, and in case of high dose chemotherapy, 8 weeks.
- Known hypersensitivity to Aplidin®, mannitol, cremophor, or ethanol or dexamethasone.
Data sourced from ClinicalTrials.gov (NCT00229203). 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.