AzTrials
AzTrials

Multiple MyelomaNCT04008888

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

A study testing Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 and Melphalan Given IV in people with Multiple Myeloma and Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 and Melphalan Given IV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
5 Jan 2018to 1 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,
Show all 13Show fewer
  • 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 -

Who cannot join

  • 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 -

Trial locations and contacts

1 site in 1 country.

WEI W SUI, Dr. contact

86-022-23909171

suiweiwei@ihcams.ac.cn

GANG AN, Dr. contact

86-022-23909171

angang@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

    WEI W SUI, Master, 86-022-23909171, suiweiwei@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma

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.

Read the 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.

Being tested
Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2, Melphalan Given IV, Fludarabine Injection, PI and dexamethasone as maintenance therapy
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Chromosome 17 deletion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HCT, SCT

    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.

  • Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2Procedure or surgery

    Also called autologous stem cell transplantation

    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.

  • Melphalan Given IVDrug

    Also called Alkeran

    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

  • Fludarabine InjectionDrug

    Also called Fludara

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

  • PI and dexamethasone as maintenance therapyDrug

    Also called VD, ID

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

  • PI+IMids+Dexamethasone as Consolidated ChemotherapyDrug

    Also called VRD, IRD, VDPACE, VDECP

    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.

Study groups in NCT04008888
Study groupRoleWhat they receive
A:Allogeneic Stem Cell Transplant GroupExperimentalFludarabine+Melphalan followed by Allogeneic SCT.
Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Melphalan Given IV; Drug: Fludarabine Injection; Drug: PI and dexamethasone as maintenance therapy
B:Autologous Stem Cell TransplantExperimentalMelphalan followed by Autologous SCT.
Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2; Drug: Melphalan Given IV; Drug: PI and dexamethasone as maintenance therapy
C:Non-TransplantExperimentalConsolidated Chemotherapy for Patients Unable to Receive Transplantation
Receives: Drug: PI and dexamethasone as maintenance therapy; Drug: PI+IMids+Dexamethasone as Consolidated Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 Year post-autograft

Secondary outcomes (5)

  1. overall response(ORR)

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

    Measured: 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.

    Measured: 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.

    Measured: 1 year post-allograft

  4. Non-relapse Mortality (NRM)

    Number of patients with non-relapse mortalities

    Measured: 1 year post-allograft

  5. Number of Patients Who Had Infections

    Number of patients who had infections

    Measured: 1 Year post-autograft

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start5 Jan 2018
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion1 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008888
Sponsor's protocol ID
IHBDH-IIT2016011
Status last verified
Jul 2019
First submitted
21 Jun 2019
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 and Melphalan Given IV in people with Multiple Myeloma and Plasma Cell Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact WEI W SUI, Dr. (86-022-23909171, suiweiwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival(PFS) (time frame: 1 Year post-autograft). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04008888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in