Clinical trial NCT04008888: a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
Official title: Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Plasma Cell Leukemia
Extramedullary Plasmacytoma
Loss of Chromosome 17p
t(14;16)
t(4;14)
T(14;20)
1Q21 Amplification
Complex Karyotype
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.

Eligibility 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 -

Primary outcomes:
measure: progression free survival(PFS)
timeFrame: 1 Year post-autograft
Secondary outcomes:
measure: overall response(ORR)
timeFrame: 1 Year post-autograft
measure: overall survival(OS)
timeFrame: 1 Year post-autograft
measure: Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
timeFrame: 1 year post-allograft
measure: Non-relapse Mortality (NRM)
timeFrame: 1 year post-allograft
measure: Number of Patients Who Had Infections
timeFrame: 1 Year post-autograft
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Lu G Qiu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: