Completed

An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma

What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: May 2004

See protocol details

Summary

Principal SponsorCallisto Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.

Official TitleAn Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma

NCT00086216 NCT00491972 NCT00301977

Principal SponsorCallisto Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma Cell

Criteria

6 inclusion criteria required to participate

documented history of multiple myeloma,

failed at least two prior regimens for multiple myeloma,

18 years of age or older,

ECOG(Zubrod)PS of 0 to 2,

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8 exclusion criteria prevent from participating

concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,

renal insufficiency (serum creatinine levels of > 2mg/dL),

mucosal bleeding,

any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

MD Anderson Cancer Center

Houston, United StatesOpen MD Anderson Cancer Center in Google Maps

CompletedOne Study Center