Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive:
Cohort 1: ZLd association:
Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle.
Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.

Patients, who are receiving Lenalidomide maintenance treatment with or without prednisone, will be randomized to receive: Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
• Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.

Multiple Myeloma

Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle

Vorinostat

Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days

Lenalidomide

Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.

Dexamethasone

Clinica di Ematologia, A.O.U. Ospedali Riuniti, Ospedale Umberto I di Ancona

U.O.S. di Ematologia, Ospedale Mazzoni

Dh ematologia, A.O.U. Careggi

Ematologia, Ospedale S. Maria della Misericordia

Ematologia e Immunoematologia, Azienda Ospedaliera Riuniti Marche Nord

Dip. Ematologia-U.O di Ematologia Generale-Azienda USL di Pescara-P.O. dello Spirito Santo

Ematologia , A.O.U. Pisana

Universitaria di Ematologia, A.O.U. San Giovanni Battista di Torino,

Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy

A Phase II, Multi-center, Open-label, Randomized Study of Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy

Determine the rate of PR with the association of ZLd and Ld in patients who experience biochemical relapse during Lenalidomide maintenance therapy. ZLd and Ld: responses will be evaluated after the enrollment of 10 and 18 pts respectively. If ≤1 and ≤2 respectively responses will be observed the trial will be stopped. Otherwise 19 and 25 pts respectively will be enrolled: if ≤5 for Zld and ≤7 for Ld responses will be observed, no further investigation will be needed

The occurrence of progression will determine the duration of PFS.

The occurence of death will determine the OS

Tiziana Marangon

Sponsor

Acute Myeloid Leukemia

Advanced Myelodysplastic Syndrome

Induction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8
Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5
Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8

Panobinostat

Induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.
Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7.
Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.

Cytarabine

Induction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.
Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4.
Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.

Daunorubicin

UCSF Helen Diller Family Comprehensive Cancer Center

Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

A Phase I Dose Finding and Proof-of-concept Study of the Histone Deacetylase Inhibitor Panobinostat (LBH589) in Combination With Standard Dose Cytarabine and Daunorubicin for Older Patients With Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

hydroxamic acid/nausea

Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy

Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

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