FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00066638 | Completed Phase 2

• 6 other identifiers: NCI-2012-03005NCI-59960403-7655996N01CM62204P30CA013330
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma

Conditions

DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Response rate (complete response [CR] or partial response [PR])

  Up to 8 years

• Event free survival

  Up to 8 years

Secondary Outcomes (2)

• Gene array parameters

  Up to 8 years

• Immunochemistry parameters

  Up to 8 years

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.

Drug: Romidepsin; Other: Laboratory Biomarker Analysis

Interventions

Romidepsin DRUG

Given IV

Treatment (romidepsin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (romidepsin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed stage IIa or IIIa multiple myeloma
• Patient has progressive disease and has had 1, 2, 3, or 4 prior lines of therapy
• Bilirubin \< 2.0 mg/dL
• SGOT/SGPT =\< 2.5 X institutional upper limit of normal
• Serum creatinine =\< 1.5 mg/dl OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Karnofsky Performance Status equal or greater than 70%; KPS 60% will be allowed if reduced KPS is due to advanced skeletal disease
• Measurable disease as defined by serum M protein \>= 1.0 gm/dl measured by serum protein electrophoresis or free light chain measurement, or quantitative immunoglobulins and/or urinary M protein excretion \>= 200 mg/24 hrs
• Ejection fraction \>= 50% and normal baseline EKG tracing
• No known central nervous system abnormality including neoplastic, vascular, inflammatory, degenerative or epilepsy
• Life expectancy of greater than 12 weeks
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL
• Patients in whom cytopenias are considered to be due to myeloma marrow infiltration will be allowed as long as they meet the following criteria:
• Bone marrow biopsy displaying \>= normal cellularity for age and \>= 50% involvement by myeloma

You may not qualify if:

• Administration of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment or unresolved adverse events due to agents administered more than 4 weeks earlier
• Prior treatment with a histone deacetylase inhibitor
• Patients may not be receiving any other investigational agent
• History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free \>= 5 years)
• Non secretory disease or plasma cell leukemia (\> 2000 circulating plasma cells/uL)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to depsipeptide
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with left ventricular hypertrophy or history of arrhythmias including atrial fibrillation, myocardial infarction or congestive heart failure; patients may not be taking hydrochlorothiazides
• Patients that are pregnant or lactating will be excluded from this trial
• Known HIV positivity; patients infected with the HIV virus will be excluded from this trial

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ruben Niesvizky-Iszaevich

  Montefiore Medical Center - Moses Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: June 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: March 1, 2011
• Last Updated: March 17, 2015

Record last verified: 2012-12

Locations

US (1)