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

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ClinicalTrials.gov Identifier: NCT05088330
Recruitment Status : Not yet recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Fu chengcheng PhD, The First Affiliated Hospital of Soochow University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Multiple Myeloma Drug: Daratumumab Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: D-VRD
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: D-VRD
treatment with D-VRD in NDMM
Drug: Daratumumab
treatment with D-VRD in NDMM
Other Name: DARA




Primary Outcome Measures :
  1. rate of minimal residual disease negativity [ Time Frame: end of 8 cycles ]
    rate of minimal residual disease negativity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    -

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Responsible Party: Fu chengcheng PhD, Principal Investigator, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT05088330    
Other Study ID Numbers: D-VRD-MM05
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antineoplastic Agents