FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 Study of Depsipeptide in Relapsed/Refractory Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Listed as NCT00066638, this PHASE2 trial focuses on DS Stage II Plasma Cell Myeloma and DS Stage III Plasma Cell Myeloma and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 8 times since 2003, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma (MM).
OUTLINE: This is a multicenter study.
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.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.
PRIMARY OBJECTIVES:
I. To evaluate the safety and efficacy of depsipeptide in patients with refractory or relapsed multiple myeloma (MM).
OUTLINE: This is a multicenter study.
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.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Jun 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .