Safety and Efficacy Assessments of Osalmid in Multiple Myeloma

May 17, 2021 updated by: Jumei Shi, Shanghai 10th People's Hospital

Safety and Efficacy Assessments of Osalmid in the Treatment of Multiple Myeloma

This study aims to evaluate the safety and efficacy of a traditional cholagogue drug osalmid, 2-hydroxy-N-(4-hydroxyphenyl)-benzamide, in the treatment of multiple myeloma (MM).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Osalmid, 2-hydroxy-N-(4-hydroxyphenyl)-benzamide, is a traditional cholagogue and is clinically used in China to promote biliary drainage and protect liver function. Studies have shown that osalmid is an inhibitor of ribonucleotide reductase (RR). Recently, it was proven by our group that osalmid induced a dose-dependent lethality in multiple myeloma (MM) cell lines H929, OPM2, U266, OCI-MY5, and RPMI 8266, as well as in MM xenograft mouse models. This study aims to assess the safety and efficacy of osalmid in the treatment of MM.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai 10th People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with age≥ 18 years old who are willing to receive the treatment of osalmid;
  2. Patients must be diagnosed with active and measurable (symptomatic) multiple myeloma according to IMWG 2003/WHO 2008(V4) MM diagnosis criteria detailed as following:1). Positive M protein in serum and/or urine; 2). Pathologically diagnosed with multiple myeloma or found colonic plasma cells in bone marrow; 3). At least one symptom of related organ damage or tissue lesion: a. hypercalcemia: serum calcium increases 0.25mmol/L or more over upper limit of normal value(ULN) or > 2.75mmol/L; b. anemia: Hemoglobin decreases 20g/L or more over lower limit of normal value(LLN) or <100g/L；c. bone lesion: lytic bone lesion or osteoporosis accompanied with compressive fracture (confirmed with MRI、CT or PET-CT); d. others: symptomatic hyperviscosity, amyloidosis, recurrent infection (more than twice within 12 months);
  3. Eastern Cancer Organization Group (ECOG) score≤2 and expected survival>2 months;
  4. Belongs to "measurable disease": serum M protein ≥10g/L and/or 24 hour urine M protein ≥200mg;
  5. No active infectious diseases;
  6. No severe organic dysfunction (except renal function insufficiency caused by multiple myeloma), lab results must meet the following criteria (within 7 days before initiation of therapy): a. Total bilirubin ≤ 1.5*ULN (same age group); b. AST and ALT ≤ 2.5*ULN (same age group); c. Cardiac enzyme < 2*ULN (same age group); d. Normal ejection fraction confirmed in echo;
  7. Able to swallow oral medicine;
  8. Volunteer to participate into this clinical trial and the informed consents must be written by patients themselves or their direct relatives. Authorized medical attorney or direct relatives can write the informed consents if it is not good for patients' treatment when consider the severity of their disease.

Exclusion Criteria:

  1. Received anti-myeloma treatment before (not include radiotherapy, bisphosphonates or single short term steroids treatment [the dose and duration of prednisone should be no more than 40mg/d and 4 days and should discontinue this treatment within 14 days before the enrollment]);
  2. Primary or secondary plasma cell leukemia;
  3. Positive HIV tests or active infection phase of HAV, HBV and HCV; or HBV DNA copies >104/ml；AST and ALT > 2.5*ULN (same age group);
  4. Severe diseases that threaten patients with unacceptable risks; these diseases include but are not confined to unstable heart diseases, which can be defined as cardiac accidents such as MI within 6 months, NYHA stage Ⅲ-Ⅳ heart failure, uncontrolled atrial fibrillation or hypertension and myeloma requiring long term administration of steroids or immune-inhibitors;
  5. Renal failure requiring hemodialysis or peritoneal dialysis;
  6. Severe embolic or thrombotic events before therapy;
  7. Major surgery within 30 days before being enrolled;
  8. Total obstruction of biliary tract;
  9. Glaucoma;
  10. History of malignancies except multiple myeloma unless being cured for more than 3 years;
  11. Severe allergic to osalmide capsule;
  12. Gestation, lactation or disagreed pregnancy;
  13. Severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis);
  14. Seizures requiring medicines, patients with dementias and other mental disorders who cannot understand or obey the protocol;
  15. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's compliance in the study or assessment of the results of the study;
  16. Severe liver and kidney dysfunction;
  17. Patients who are considered unsuitable for enrollment by investigators.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Osalmid
Participants are initially given oral capsules with 0.5g tid osalmid daily for two weeks. Thereafter, the dosage will be increased by 0.25g tid every two weeks as tolerated by participants to a maximum daily dosage of 1.0g tid for up to one year. One course of osalmid treatment lasts four weeks. Response will be assessed at the end of each treatment course, and patients who have achieved MR (minor remission) or more than MR at the end of the fourth course will continue to take 1.0g tid osalmid daily for consolidation / maintenance therapy. Otherwise, patients who have not achieved MR at the end of the fourth course and patients who are assessed for PD (progression of disease) at the end of each course will receive salvage treatment, such as a combined treatment of osalmid and dexamethasone or the VCD (bortezomib, cyclophosphamide and dexamethasone) regimen.
Drug: Osalmid
Participants are initially given oral capsules with 0.5g tid osalmid daily for two weeks. Thereafter, the dosage will be increased by 0.25g tid every two weeks as tolerated by participants to a maximum daily dosage of 1.0g tid for up to one year.
Other Names:
  • 2-hydroxy-N-(4-hydroxyphenyl)-benzamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: at week16
M protein qualification in serum and/or urine decline of at least 25%, 50%, 75%, or 90%
at week16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to progression
Time Frame: at week 48
from the start of therapy to disease progression
at week 48
duration of response
Time Frame: at week 48
from the time response was achieved to disease progression or death
at week 48
progression-free survival
Time Frame: at week 48
from study entry to disease progression or death
at week 48
overall survival
Time Frame: at week 48
from the date of study entry to the date of death or last follow-up
at week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Investigators

  • Study Director: Jumei Shi, MD PhD, Shanghai 10th People's Hospital
  • Principal Investigator: Weiliang Zhu, PhD, Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ANTICIPATED)

May 18, 2021

Study Completion (ANTICIPATED)

May 18, 2021

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (ACTUAL)

September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STPH-MM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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