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

Institute of Hematology & Blood Diseases Hospital, China

Status: Unknown

Conditions: 1Q21 Amplification; Plasma Cell Leukemia; Loss of Chromosome 17p; Extramedullary Plasmacytoma; Multiple Myeloma; Complex Karyotype; t(4;14); T(14;20); t(14;16)

Treatments: Drug: PI+IMids+Dexamethasone as Consolidated Chemotherapy; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: PI and dexamethasone as maintenance therapy; Drug: Fludarabine Injection; Drug: Melphalan Given IV; Procedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04008888

IHBDH-IIT2016011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 3 patient groups

A:Allogeneic Stem Cell Transplant Group

Experimental group

Description:

Fludarabine+Melphalan followed by Allogeneic SCT.

Treatment:

Drug: Fludarabine Injection

Drug: Melphalan Given IV

Drug: PI and dexamethasone as maintenance therapy

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

B:Autologous Stem Cell Transplant

Experimental group

Description:

Melphalan followed by Autologous SCT.

Treatment:

Drug: Melphalan Given IV

Procedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2

Drug: PI and dexamethasone as maintenance therapy

C:Non-Transplant

Experimental group

Description:

Consolidated Chemotherapy for Patients Unable to Receive Transplantation

Treatment:

Drug: PI+IMids+Dexamethasone as Consolidated Chemotherapy

Drug: PI and dexamethasone as maintenance therapy