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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00863174

Enrollment

Registered

2009-03-17

Start date

2010-11-30

Completion date

2011-04-30

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple myeloma, Bio-equivalence

Brief summary

Safety and bioequivalence of SPARC\_147709

Interventions

DRUGSPARC147709

SPARC147709 injection

DRUGReference147709

Reference147709 injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference	2 cycles

Secondary

Measure	Time frame
Treatment Emergent Adverse Events	2 cycles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026