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Clinical Study of Safety and Tolerability of Melphalan Hydrochloride for R/R MM

NCT05438394 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-14

No results posted yet for this study

Summary

This study is an investigator-initiated clinical study to evaluate the safety and tolerability of melphalan hydrochloride for injection in patients with relapsed or relapsed refractory multiple myeloma. Using the "3 + 3" dose escalation principle, 3-6 subjects per dose were enrolled, depending on the dose limiting toxicity (DLT) observed in the first cycle of chemotherapy for each subject. After completing the 21-day assessment of the first cycle of chemotherapy, if there was no DLT, the study started for the next dose group.

Conditions

Interventions

DRUG

melphalan hydrochloride for injection

Intravenous (iv) infusion for 20 minutes on Day 1 of a 21-day chemotherapy cycle

Sponsors & Collaborators

  • CASI Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Jin Lu · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438394 on ClinicalTrials.gov