Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- progression free survival(PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 -
Arms & Interventions
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
Intervention: Melphalan Given IV (Drug)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
Intervention: Fludarabine Injection (Drug)
A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
Intervention: PI and dexamethasone as maintenance therapy (Drug)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
Intervention: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 (Procedure)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
Intervention: Melphalan Given IV (Drug)
C:Non-Transplant
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
Intervention: PI and dexamethasone as maintenance therapy (Drug)
B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
Intervention: PI and dexamethasone as maintenance therapy (Drug)
C:Non-Transplant
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
Intervention: PI+IMids+Dexamethasone as Consolidated Chemotherapy (Drug)
Outcomes
Primary Outcomes
progression free survival(PFS)
Time Frame: 1 Year post-autograft
PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.
Secondary Outcomes
- Non-relapse Mortality (NRM)(1 year post-allograft)
- overall survival(OS)(1 Year post-autograft)
- Number of Patients Who Had Infections(1 Year post-autograft)
- overall response(ORR)(1 Year post-autograft)
- Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease(1 year post-allograft)
Investigators
Qiu Lugui
Chief physician
Institute of Hematology & Blood Diseases Hospital, China