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

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• Multiple Myeloma 3,632
• Neoplasms, Plasma Cell 2,306
• Plasmacytoma 351
• Leukemia, Plasma Cell 63

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Study arms

• Experimental
  A:Allogeneic Stem Cell Transplant Group

  Fludarabine+Melphalan followed by Allogeneic SCT.

  Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Drug: Melphalan Given IV · Drug: Fludarabine Injection · Drug: PI and dexamethasone as maintenance therapy

• Experimental
  B:Autologous Stem Cell Transplant

  Melphalan followed by Autologous SCT.

  Procedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 · Drug: Melphalan Given IV · Drug: PI and dexamethasone as maintenance therapy

• Experimental
  C:Non-Transplant

  Consolidated Chemotherapy for Patients Unable to Receive Transplantation

  Drug: PI and dexamethasone as maintenance therapy · Drug: PI+IMids+Dexamethasone as Consolidated Chemotherapy

Interventions

• ProcedureAllogeneic Hematopoietic Stem Cell Transplantation

  Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients.

  Also known as: Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HCT, SCT

• ProcedureAutologous Hematopoietic Stem Cell Transplantation x 1 or x 2

  Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT.

  Also known as: autologous stem cell transplantation

• DrugMelphalan Given IV

  conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m\^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes

  Also known as: Alkeran

• DrugFludarabine Injection

  conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV

  Also known as: Fludara

• DrugPI and dexamethasone as maintenance therapy

  Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

  Also known as: VD, ID

• DrugPI+IMids+Dexamethasone as Consolidated Chemotherapy

  Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11\&12 of each 21-day.

  Also known as: VRD, IRD, VDPACE, VDECP

Primary outcomes

1. progression free survival(PFS)

   PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.

   Time frame: 1 Year post-autograft

Secondary outcomes

1. overall response(ORR)

   ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria

   Time frame: 1 Year post-autograft

2. overall survival(OS)

   OS is defined as the duration from the data of registration to death.If the subject is alive, the data will be censored as being alive; the vital status is unknown as last known.

   Time frame: 1 Year post-autograft

3. Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease

   aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death cGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

   Time frame: 1 year post-allograft

4. Non-relapse Mortality (NRM)

   Number of patients with non-relapse mortalities

   Time frame: 1 year post-allograft

5. Number of Patients Who Had Infections

   Number of patients who had infections

   Time frame: 1 Year post-autograft

Individual participant data

Plan to share: No