Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: bortezomib; Drug: vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111813

0683-015

2005_018

Details and patient eligibility

About

The purposes of this study are:

• To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
• To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with refractory or relapsed multiple myeloma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
• Adequate bone marrow reserve
• Adequate hepatic and renal function
• Ability to swallow capsules
• 3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion criteria

• Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
• Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
• Participants with other active/uncontrolled clinically significant illness
• Pregnant or nursing female participants
• Participants who received bortezomib within 3 months of start of this trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 6 patient groups

vorinostat 200 mg + bortezomib 0.7 mg/m^2

Experimental group

Description:

Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib

vorinostat 200 mg + bortezomib 0.9 mg/m^2

Experimental group

Description:

Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib

vorinostat 300 mg + bortezomib 1.3 mg/m^2

Experimental group

Description:

Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib

vorinostat 400 mg + bortezomib 0.9 mg/m^2

Experimental group

Description:

Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib

vorinostat 400 mg + bortezomib 1.1 mg/m^2

Experimental group

Description:

Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib

vorinostat 400 mg + bortezomib 1.3 mg/m^2

Experimental group

Description:

Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.

Treatment:

Drug: vorinostat

Drug: bortezomib