UnknownNot Applicable

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

China50 participantsStarted 2018-01-05

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Clinical diagnosis of high-risk multiple myeloma
✓. candidate for high-dose chemotherapy with stem cell transplantation
✓. ECOG performance status score of 0,1,or2 -

Exclusion criteria

✕. The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia.
✕. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer.
✕. according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above:
✕. 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 -

What they're measuring

progression free survival(PFS)

Timeframe: 1 Year post-autograft

Trial details

NCT IDNCT04008888

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-01

Contact for this trial

WEI W SUI, Dr.

86-022-23909171 suiweiwei@ihcams.ac.cn

View on ClinicalTrials.gov More Multiple Myeloma trials