Overview

Safety and Efficacy Assessments of Osalmid in Multiple Myeloma

Status:
Active, not recruiting
Trial end date:
2021-05-18
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai 10th People's Hospital
Collaborator:
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Criteria
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.