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Multiple MyelomaPhase 1NCT02077959

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

A Phase 1 study testing lenalidomide, pidilizumab and pharmacological study in people with Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
lenalidomide, pidilizumab and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
3 Mar 2014to 24 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Patients must provide informed consent
  • Patients must have a left ventricular ejection fraction > 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
  • Patients must have a Karnofsky performance status >= 70
  • A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
  • Fertility requirements:
  • Female patients with child bearing potential must have a negative pregnancy test at least 7 days before starting treatment drugs
  • Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days afterwards
  • Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and for 90 days afterwards
  • Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Phase I/II Study of Lenalidomide in Combination With Anti-PD-1 Monoclonal Antibody CT-011 in Patients With Relapsed/Refractory Multiple Myeloma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD), safety and efficacy of CT-011 (pidilizumab) in combination with lenalidomide (Revlimid) and assess efficacy in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM).

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study but this phase did not move forward.

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

After completion of study treatment, patients are followed up at 30 days.

Being tested
lenalidomide, pidilizumab, pharmacological study, laboratory biomarker analysis
Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • pidilizumabBiological

    Also called CT-011

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT02077959
Study groupRoleWhat they receive
Treatment (lenalidomide, pidilizumab)ExperimentalPatients 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.
Receives: Drug: lenalidomide; Biological: pidilizumab; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 28 days

  2. 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.

    Measured: Up to 30 days

Secondary outcomes (3)

  1. Time to progression

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

  2. Overall survival (Phase II)

    OS will be evaluated using the methods of Kaplan-Meier.

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

  3. Pharmacokinetic parameters of pidilizumab in combination with lenalidomide

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study start3 Mar 2014
  3. Primary completion24 May 2019
  4. Study completion24 May 2019

Why it stopped: Pharmaceutical Companies decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077959
Sponsor's protocol ID
OSU-13128
Other IDs
NCI-2014-00385
Status last verified
Nov 2022
First submitted
28 Feb 2014
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide, pidilizumab and pharmacological study in people with Multiple Myeloma, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Pharmaceutical Companies decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077959.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.

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