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Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

ConditionsMultiple MyelomaPrimary Plasma Cell LeukemiaExtramedullary Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)"Double hit"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia.

Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.

Aged 18 years to 70 years.

Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).

Disqualifiers

No evidence of high-risk disease.

Primary diagnosis of Waldenstrom's disease/POEMS syndrome/light chain amyloidosis.

Received therapy for multiple myeloma.

Prior or concurrent invasive malignancies.

Trial design

Design model

Single group

Treatments tested in this trial

  • Daratumumab

    Drug

    Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.

  • Carfilzomib

    Drug

    Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.

  • Lenalidomide

    Drug

    Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.

  • Dexamethasone

    Drug

    Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance

  • Cisplatin

    Drug

    Given by vein: days 1-4 of each Induction cycle

  • epirubicin

    Drug

    Given by vein: days 1-4 of each Induction cycle

  • Cyclophosphamide

    Drug

    Given by vein: days 1-4 of each Induction cycle

  • Etoposide

    Drug

    Given by vein: days 1-4 of each Induction cycle

  • Melphalan

    Drug

    Given by vein: day -1 of Transplant

  • ASCT

    Procedure/Surgery

    day 0 of Transplant

  • bortezomib

    Drug

    given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Study TreatmentExperimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

2-year progression-free survival

2-year Progression-free survival of participants as determined by investigator assessment.

Time frame
24 months

Secondary outcomes

1

progression-free survival

progression-free survival of participants as determined by investigator assessment.

Time frame
36 months
2

overall survival

overall survival of participants as determined by investigator assessment.

Time frame
36 months
3

overall response rate

Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

Time frame
36 months
4

minimal residual disease negativity rate

Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing.

Time frame
36 months

Other outcomes

Sponsors and contacts

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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov
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