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Safety of Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma, A Phase I/II Study, Short Title: VBDD


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma in Relapse

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Trial Information

Safety of Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma, A Phase I/II Study, Short Title: VBDD


A first cohort of three patients will be treated at the starting dose level of Vorinostat
100 mg/d, on day 1-4, 8-11, and 15-18 in combination with BDD.

The dose level of Vorinostat will be escalated in each new cohort:

if no dose limiting toxicity (DLT) has been observed in the previous dose level in 3
patient, the second cohort of 3 new patients will be treated with Vorinostat 200 mg/d and
the third cohort will be given Vorinostat with 300 mg/d.

Bortezomib will be administered intravenously (i.v.) 1.3mg/m2 d1, 8, 15. Doxorubicin will be
administered i.v. with a total dose of 18 mg/m2 per cycle (9 mg/m2, d1 and 8).

Dexamethasone will be administered per os (p.o.) with 40mg (first cycle) and 20mg (all other
subsequent cycles) on d1, 8, 15, 22.


Inclusion Criteria:



- Patients with refractory or relapsed MM after at least first-line chemotherapy (CTx)
or PBSCT (autologous and allogeneic SCT). All lines of relapse are eligible.

- KPS ≥60%

- Adequate BM function

- Adequate hepatic and renal function (AST and ALT ≤2.5 times ULN, Bilirubin ≤1.5 times
ULN, eGFR >20 ml/min)

Exclusion Criteria:

- Patient has had prior treatment with Vorinostat or HDAC inhibitors

- Patients with severe hepatic impairment or acute diffuse infiltrative pulmonary and
pericardial disease

- Patient has preexisting NCI CTC ≥grade 3 neuropathy

- Patient with known CNS MM-involvement and/or MM-related/induced meningitis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximal Tolerated Dose (MTD)

Outcome Description:

The Maximal Tolerated Dose (MTD) is estimated as the highest dose at which less than two DLTs in 6 patients are observed in the first cycle. MTD estimation is based on the phase I part of the trial. However, the number of DLT's in the first cycle of the phase II patients will be inspected and discussed as well. The primary target variable is the occurrence of any dose-limiting toxicity (DLT) in MM patients during the first 28 days of treatment.

Outcome Time Frame:

28 days (within first treatment cycle)

Safety Issue:

Yes

Principal Investigator

Monika Engelhardt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Freiburg Medical School

Authority:

Germany: Bundesinstitut für Arzneimittel und Medizinprodukte, Klinische Studien, Kurt-Georg-Kiesinger-Allee 3,53175 Bonn

Study ID:

00658, MK-0683-201

NCT ID:

NCT01394354

Start Date:

August 2011

Completion Date:

September 2014

Related Keywords:

  • Multiple Myeloma in Relapse
  • Multiple Myeloma relapsed refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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