Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma

NCT01755975 | Completed Phase 1 Results

• 1 other identifier: 12-170
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

Conditions

Multiple Myeloma; Non-Hodgkin's Lymphoma

Keywords

LENALIDOMIDE (CC-5013); Romidepsin (Istodax); 12-170

Outcome Measures

Primary Outcomes (2)

• Number of Dose Limiting Toxicities/DLTs

  The phase Ib portion of the study is designed to determine the MTD of romidepsin and lenalidomide.

  1 year

• Number of Participants Evaluable for AEs

  Subjects will be evaluated for AEs at each visit with the NCI CTCAE v4.0 used as a guide for the grading of severity.

  1 year

Secondary Outcomes (3)

• Assess the Overall Response Rate (ORR)

  1 year

• Complete Response Rate/CRR

  1 year

• Assess the Time to Best Response (TTBR)

  up to 50 months

Study Arms (1)

Romidepsin and Lenalidomide

EXPERIMENTAL

This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.

Drug: Romidepsin; Drug: Lenalidomide

Interventions

Romidepsin DRUG

Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle.

Romidepsin and Lenalidomide

Lenalidomide DRUG

Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.

Romidepsin and Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Pathology confirmed lymphoma or multiple myeloma
• Hodgkin lymphoma is eligible for either phase and will be considered a B-cell lymphoma in the phase IIa study.
• Phase IIa portion, subjects must have B-cell lymphoma, T-cell lymphoma, or multiple myeloma.
• Relapse or progression after at least 1 systemic therapy.
• Measurable disease for phase IIa portion only.
• Lymphoma (includes CTCL patients who are NED in skin): CT or PET/CT by modified Cheson criteria with incorporation of PET.
• Multiple myeloma:.Patient must have measurable disease and therefore must have at least one of the following:
• i. Serum M-protein ≥0.5gm/dL (≥5gm/L) ii. Urine M-protein ≥200mg/24hr iii. Serum FLC assay: involved FLC ≥10mg/dL (≥100mg/L) provided serum FLC ratio is abnormal.
• CTCL: mSWAT \>0, or absolute Sezary count ≥ 1000 cells/μL.
• Age ≥18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment in this study. If there is progression of disease on that therapy and all adverse effects have resolved to Grade 1 or baseline, in which case 2 weeks is acceptable.
• Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (\< 7 days) must have been discontinued at least 7 days prior to study treatment. Stable ongoing corticosteroid use (≥ 30 days) up to an equivalent dose of 15 mg of prednisone is permissible.
• ECOG performance status of ≤ 2 at study entry
• Laboratory test results within these ranges:

You may not qualify if:

• Patients who have a standard curative option for their lymphoid malignancy at current state of disease are excluded. For eligibility on this trial, allogeneic stem cell transplantation is not to be considered a standard curative option.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant females. (Lactating females must agree not to breast feed while taking lenalidomide or romidepsin).
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Prior use of lenalidomide if discontinued due to toxicity.
• Prior therapy with romidepsin if discontinued due to toxicity.
• Concurrent use of other anti-cancer agents or treatments.
• Known seropositive and requiring anti-viral therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Active concurrent malignancy requiring active therapy.
• Known central nervous system or meningeal involvement (in the absence of symptoms investigation into central nervous system involvement is not required). Patients with HTLV1 ATLL and controlled CNS or meningeal involvement may be enrolled after discussion with the MSK principal investigator.
• The following known cardiac abnormalities:
• Congenital long QT syndrome.
• QTc interval ≥ 480 milliseconds
• A QTc interval between 480-499 msec in the presence of a bundle branch block (BBB) or pacemaker is are eligible in phase IIa after discussion with the MSK principal investigator

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• St. Francis Hospital & Medical Center, Hartford CT: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Nebraska: collaborator
• Celgene Corporation: collaborator
• Biologics, Inc.: collaborator

Study Sites (7)

Saint Francis/Mount Sinai Regional Cancer Center

Hartford, Connecticut, 06105, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical Center

New York, New York, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

romidepsin; Lenalidomide

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; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Steven Horwitz, MD
• Organization: Memorial Sloan Kettering Cancer Center

horwitzs@mskcc.org

646-608-2680

Study Officials

• Steven Horwitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2023-10

Locations

US (7)