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Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

ConditionsNewly DiagnosedHigh RiskMRDMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;

age ≥ 18 years;

have an evaluable lesion; serum M protein ≥ 10 g/L, or urinary light chain ≥ 200 mg/24h, or involved serum free light chain (FLC) ≥ 100 mg/L, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules can be measured with a manual tape, and extramedullary tumor SPD of extramedullary tumors is measured on a CT scan as the product of the largest dimension of the largest pendulous diameter of the lesion (minimum diameter of 5mm or more), parosteal lesions need to be in soft tissue outside the bone cavity to meet the above criteria. MRI measures the size of an extramedullary tumor as the product of the maximum pendulous diameter at the level of the largest area of the tumor (minimum diameter of 5mm or more)

ECOG physical status score ≤ 2

Disqualifiers

monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.

diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.

other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any adjuvant therapy considered investigational.

peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration

Trial design

Design model

Single group

Treatments tested in this trial

  • Carfilzomib

    Drug

    Induction: ASCT：20mg/56mg/m2 ,D1,8,15，C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15，C2-4; Consolidation: ASCT: 56mg/m2 ,D1,8,15，C5-6; non ASCT: 36mg/m2 ,D1,8,15，C5-8; Maintenance: ASCT: 70mg/m2 ，D1，15; non-ASCT：56mg/m2 ，D1，15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued

  • Daratumumab

    Drug

    28d/Cycle Induction: 16mg/kg, D1,8,15,22，C 2-3，16mg/kg, D1,15, C4; Consolidation: ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8; Maintenance: 16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued

  • Lenalidomide

    Drug

    28d/Cycle Induction: 25mg qd d1-21 C2-C4; Consolidation: ASCT: 10mg d1-21，C5-6; non ASCT: 25 mg d1-21，C5-8; Maintenance: 10mgqd D1-21 After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression

  • Dexamethasone

    Drug

    28d/Cycle Induction: ASCT：40mg qd, po/iv，D1,8,15,22，C2-4; non ASCT:20mg qd, po/iv，D1,8,15,22，C2-4; Consolidation: ASCT: 40mg qd, po/iv，D1,8,15,22，C5-6; non ASCT:20mg qd, po/iv，D1,8,15,22，C5-8

  • VRD for first-cycle induction therapy

    Drug

    Induction: C1, 28d/cycle Bortezomib(V）:1.3 mg/m2，H，d1、4、8、11； Lenalidomide(R)：25mg，po. qd d1-14; Dexamethasone(D)：20 mg，po/iv，D1，2, 4，5, 8，9, 11,12。

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: DKRdExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

MRD negative rate

the rate of minimal residual disease negativity

Time frame
Completion of consolidation therapy

Secondary outcomes

1

≥VGPR rate

the rate of very good partial response or better

Time frame
after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
2

overall response rate

the rate pf overall response

Time frame
after completion of induction therapy (about 4 months after enrollment) and consolidation therapy(about 11 months after enrollment) , respectively
3

adverse events

the rate of adverse events and grade of adverse events

Time frame
from enrollment to completion of following up, about 2 years
4

PFS

Progression-free survival

Time frame
from enrollment to completion of one-year maintenance therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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