A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

October 10, 2021 updated by: Fu chengcheng PhD, The First Affiliated Hospital of Soochow University

A Prospective Study of Daratumumab Combined With VRD in the Treatment of Patients With Newly Diagnosed Standard-risk Multiple Myeloma : a Single-center, Single-arm Clinical Study

This is an open-label, single arm study to access the effect of treatment with D-VRD in patients with newly diagnosed standard risk multiple myeloma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Research object:Newly diagnosed standard-risk multiple myeloma (NDMM) diagnosed according to the International Myeloma Working Group (IMWG) standards and who have been assessed to receive Autologous Stem Cell Transplantation (ASCT) but actively refused.Objective: To explore the therapeutic options of daratumamab (D) combined with bortezomib (V), lenalidomide (R) and dexamethasone ( d) for objective assessment of patients who can receive ASCT but not to receive transplantation.Main indicators:negative rate of minimal residual disease (MRD) upon completion of cycle 8 (24 weeks).

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Age ≥ 18 years and ≤ 70 years, male or female；
  2. Newly diagnosed multiple myeloma (NDMM) ；
  3. Transplant-eligible；
  4. Non-17p-, t(4;14) , t(14;16)；
  5. Expected survival ≥12 weeks;
  6. Eastern Cooperative Oncology Group (ECOG) scores 0 - 2.

  7. Subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments):

    1. Complete blood count (CBC) results: absolute neutrophil count（ANC） ≥ 1.0 × 109/L, platelet count ≥ 75 × 109/L (if the proportion of plasma cells in the bone marrow is > 50%, subjects with platelets ≥ 50 × 109/L will be eligible), Hb ≥ 70 g/L.
    2. Blood biochemistry: creatinine clearance ≥ 30 mL/min, alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN)，aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN. Serum calcium ≤14.0 mg/dL (≤3.5 mmol/L);
  8. Normal cardiopulmonary function;
  9. The patient agrees to join the clinical trial and signs an informed consent form.

Exclusion Criteria

  1. Poor hypertension control;
  2. Have received ASCT or anti-tumor systemic therapy;
  3. Peripheral neuropathy or neuralgia of grade 2 or higher;
  4. During pregnancy or lactation or planning to become pregnant;
  5. History of other malignant tumors within 5 years;
  6. Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA.
  7. Participating in other clinical trials;
  8. Allergic to the drugs in the treatment plan;
  9. Receiving any other experimental drugs or experimental medical devices;
  10. The investigator believes that the patient has other conditions that are not suitable for participating in this study.

  11. Patients with R-ISS Phase III

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: D-VRD
treatment with D-VRD in NDMM
Drug: Daratumumab
treatment with D-VRD in NDMM
Other Names:
  • DARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of minimal residual disease negativity
Time Frame: end of 8 cycles
rate of minimal residual disease negativity
end of 8 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

May 30, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

October 10, 2021

First Posted (ACTUAL)

October 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 10, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-VRD-MM05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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