Clinical trial · Interventional
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
NCT00863174CI-TRIAL-00038433completedPhase 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)
Safety and bioequivalence of SPARC\_147709
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 |
|---|---|---|---|
| Reference147709 | Drug | — | UNRESOLVED |
| SPARC147709 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- SPARC147709
- interventionNames
- Drug: SPARC147709
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Reference147709
- interventionNames
- Drug: Reference147709
Primary outcomes (1)
- measure
- 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
- timeFrame
- 2 cycles
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Availability for the entire study period and willingness to adhere to protocol requirements. * Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome * 18 years of age or older * No evidence of underlying disease (except multiple myeloma) Exclusion Criteria: * History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride * History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease. * History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day). * Positive result to HIV, HCV, RPR and HBsAg.
References
Publications (0)
Data not yet available
No reference posted for this study.