A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

Multiple Myeloma Clinical Trial

Official title:

Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00109109
• Other study ID #: 0683-004
• Secondary ID: 2005_013
• Status: Terminated
• Phase: Phase 1
• Start date: December 1, 2003
• Est. completion date: February 14, 2006

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of this study are:

• To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;

• To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: February 14, 2006
• Est. primary completion date: February 14, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)

• Adequate bone marrow reserve

• Adequate hepatic and renal function

• Ability to swallow capsules

• 3 weeks or more from prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

• Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment

• Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism

• Patients with other active/uncontrolled clinically significant illnesses

• Pregnant or nursing female patients

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Richardson P, Mitsiades C, Colson K, Reilly E, McBride L, Chiao J, Sun L, Ricker J, Rizvi S, Oerth C, Atkins B, Fearen I, Anderson K, Siegel D. Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple mye — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
Primary	PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Secondary	1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.