Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT02077959 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-13128NCI-2014-00385
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I/II trial studies the side effects and best dose of lenalidomide and pidilizumab and to see how well they work in treating patients with multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as pidilizumab, can block cancer growth by blocking the ability of cancer to grow and spread. Giving lenalidomide with pidilizumab may work better in treating relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• MTD of pidilizumab combined with lenalidomide defined as the dose level at which no more than one of 6 patients experiences a dose-limiting toxicity (Phase I)

  28 days

• Overall response rate in responding patients according to the IMWG response criteria (Phase II)

  The proportion of responses (partial and complete) will be calculated out of all eligible patients who receive any treatment in that disease group who are included in the phase II assessment. Assuming the number of responses is binomially distributed, 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.

  Up to 30 days

Secondary Outcomes (3)

• Time to progression

  Time from start of treatment until progression or death, assessed up to 30 days

• Overall survival (Phase II)

  Time from start of treatment to the date of his or her death, assessed up to 30 days

• Pharmacokinetic parameters of pidilizumab in combination with lenalidomide

  Baseline, immediately at the end of infusion, 1, 24, 72, 168, and 336 hours, and just prior to course 2

Other Outcomes (3)

• Assess CT-011 Immunogenicity of pidilizumab

  Up to 30 days

• Assess Immunomonitoring of lymphoctes to includeT and NK cell subsets

  Up to 30 days

• Ex-vivo assessment of immune functional activities

  Up to 30 days

Study Arms (1)

Treatment (lenalidomide, pidilizumab)

EXPERIMENTAL

Patients receive lenalidomide PO daily on days 1-21 and pidilizumab IV over 1-2 hours on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lenalidomide; Biological: pidilizumab; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

lenalidomide DRUG

Given PO

Also known as: CC-5013, IMiD-1, Revlimid

Treatment (lenalidomide, pidilizumab)

pidilizumab BIOLOGICAL

Given IV

Also known as: CT-011

Treatment (lenalidomide, pidilizumab)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (lenalidomide, pidilizumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lenalidomide, pidilizumab)

Eligibility Criteria

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

You may qualify if:

• Patients have evidence of relapse or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following:
• Serum M-protein \>= 0.5 g/dl (\>= 10 g/l)
• Urine monoclonal protein \>= 200 mg/24h
• Involved free light chain (FLC) level \>= 10mg/dl (\>= 100mg/l) and an abnormal serum free light chain ratio (\< 0.26, or \> 1.65)
• Measurable biopsy proven plasmacytoma (should be measured within 28 days of initial investigational agent dosing)
• Patients must have had at least 2 prior line of therapy
• Patients must not have had progression of disease on lenalidomide 25 mg; stable disease on lenalidomide is permitted
• Patient may be enrolled at any time from last line of therapy
• Absolute neutrophil count (ANC) \> 1000/uL
• Platelets \>= 75,000/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is \> 30%, platelet eligibility requirement will be adjusted to 60,000/uL
• Total bilirubin =\< 1.5 mg/dL
• Alkaline phosphatase =\< 3 X the upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2 X the ULN
• Serum creatinine =\< 2 mg/dL or calculated creatinine clearance of \>= 40 ml/min within 14 days of registration using Modification of Diet in Renal Disease (MDRD) formula
• Patient must be able to swallow capsule or tablet

You may not qualify if:

• Patients with peripheral neuropathy \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2
• Prior exposure to anti programmed cell death 1 (PD1) or anti programmed cell death 1 ligand 1 (PDL1)
• Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
• History of allergic reaction (including erythema nodosum) to lenalidomide
• Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
• Patients with contraindication to thromboprophylaxis
• Unacceptable cardiac risk factors defined by any of the following criteria: patients with congenital long QT syndrome, any history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate (HR) \< 50 bpm, left ventricular ejection fraction \< 30%
• Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies
• Patients who have undergone major surgery =\< 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
• Patients with known positivity for human immunodeficiency virus (HIV), or hepatitis C; baseline testing for HIV and hepatitis C is not required
• Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from a prior malignancy for \>= 5 yrs and are considered by their physician to be less than 30% risk of relapse
• Patients with active (untreated or relapsed) central nervous system (CNS) metastasis of the patient's myeloma
• Patients with a history of gastrointestinal surgery or other procedure that might, in the opinion of the investigator(s), interfere with the absorption or swallowing of the study drugs
• Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff
• Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• CureTech Ltd: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; pidilizumab

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

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

Study Officials

• Yvonne Efebera

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

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: February 28, 2014
• First Posted: March 4, 2014
• Study Start: March 3, 2014
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: January 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)