a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Fludarabine; Fludarabine phosphate; Melphalan

Criteria

Inclusion Criteria:

1. Clinical diagnosis of high-risk multiple myeloma

In addition, patients must meet at least one of the following criteria I-IX (I-VIII at time of diagnosis or pre-autograft):

I.Complex karyotype

II.Fluorescent in situ hybridization (FISH) translocation 4:14 or 14:16,

III.FISH translocation 1q21,

IV.FISH deletion 17p,

V.R-ISS III stage,

VI.Two or more high-risk cytogenetic abnormalities exist

VII.Plasma cell leukemia

VIII.Extramedullary plasmacytoma

IX.Recurrent or non-responsive (less than partial remission [PR]) MM after at least 4 cycles of PI/IMids-based chemotherapy

2. candidate for high-dose chemotherapy with stem cell transplantation

3. ECOG performance status score of 0,1,or2 -

Exclusion Criteria:

1. The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia.

2. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer.

3. according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above:

4. were enrolled within 6 months before had a myocardial infarction, or New York Heart Association (NYHA) III or IV heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ECG evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -