Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05054478
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Plasma Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab added to induction, first consolidation and second consolidation

Study Details

Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.

Key Dates

Start date
Oct 31, 2021
Status verified
May 2021
Primary completion
Jun 30, 2024
Completion
Feb 29, 2028

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    4 days of dexamethasone. According to local practice, one dose of doxorubicine (30 mg/m2 IV) or cyclophosphamide (750 mg/m2 IV) may also be added Induction Treatment (4 months): Subject will receive 4 x 28 days cycles of Dara-VRD induction: Daratumumab sc 1800 mg on D1 D8 D15 D22 for cycle1 \& 2 and D1 D15 for cycle 3 \& 4 Bortezomib sc 1.3 mg/m2 on D1 D4 D8 D11 for each cycle Lenalidomide po 25 mg on D1 to D21 for each cycle Dexamethasone po 20 mg on D1 D2 D8 D9 D15 D16 D22 D23 for each cycle High dose melphalan 200mg/m2 as conditioning therapy and first ASCT First consolidation : 2 cycles of Dara-VRd * Daratumumab 1800 mg s.c D1 D15 * Bortezomib 1.3 mg/m2 s.c D1 D8 D15 D22 * Lenalidomide 25 mg p.o from D1 to D21 * Dexa 20 mg p.o D1 D8 D15 D22 High dose melphalan 200mg/m2 as conditioning therapy and second ASCT Second consolidation : 6 cycles of Dara-VRd (every 2 months for 2 years) Then maintenance: Lenalidomide every 28 days (25 mg from D1 to D21) for 1 year

Primary Outcome Measure

VGPR or better at the completion of induction phase [ Time Frame: completion of induction phase [4 Months] ]

Central Contacts

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