ClinicalTrials.gg
CompletedNCT01075321Updated Oct 22, 2020Results posted

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

A Phase 1/2 interventional study of everolimus and lenalidomide in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic — none open to participants now, 1 under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · Mayo Clinic.

Enrollment
6th of 10
58 · median 91
Started
2011
with 1 other
Phase 1/2
2 of 11
none open now
Registered
7th of 11
by date

Among the 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic, this one is the 6th largest by enrollment of the 10 interventional ones, is one of 2 that started in 2011, is one of 2 in phase 1/2, and was the 7th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Phase 24 · 0 open
No phase2 · 0 open
Phase 1/2this study2 · 0 open
Observational1 · 0 open
Phase 11 · 0 open
Phase 31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 2 started in 2011.

Size and results

Median enrollment 91 across the 10 interventional studies, 17 across the 1 observational. Of the 10 that completed or were terminated, 8 (80%) have results posted.

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Download CSVWith an account: the 11 studies in Lymphoma, Extranodal NK-T-Cell by Mayo Clinic as a file.
02

Study summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

I.Phase I: To establish the maximum tolerated dose of EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma.

II. Phase II: To assess tumor response to EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma.

SECONDARY OBJECTIVES:

I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving EVEROLIMUS and lenalidomide.

II. To describe the adverse event profile (using CTCAE CTEP Version 4.0) of EVEROLIMUS and lenalidomide.

OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

03

Conditions studied

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Splenic Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological or cytological confirmation of non-Hodgkin lymphoma or Hodgkin lymphoma =\< 6 months prior to registration
  • The following disease types are eligible: Study 1 - Aggressive lymphomas- Transformed lymphomas; Diffuse large B cell lymphoma; Mantle cell lymphoma; Follicular lymphoma grade III; Precursor B lymphoblastic leukemia/lymphoma; Mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; Precursor T lymphoblastic leukemia/lymphoma; Primary cutaneous anaplastic large cell lymphoma; and Anaplastic large cell lymphoma-primary systemic type
  • Study 2- Indolent lymphomas: Follicular lymphoma, grades 1, 2; Extranodal marginal zone B-cell lymphoma of MALT type; Nodal marginal zone B-cell lymphoma; Splenic marginal zone B-cell lymphoma; Small lymphocytic lymphoma
  • Study 3- Uncommon lymphomas: Peripheral T cell lymphoma, unspecified; Anaplastic large cell lymphoma (T and null cell type); Lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); Post transplant lymphoproliferative disorders; Mycosis fungoides/Sezary syndrome; Hodgkin Disease; Primary effusion lymphoma; Adult T-cell leukemia/lymphoma; Extranodal NK/T-cell lymphoma, nasal type; Enteropathy-type T-cell lymphoma; Hepatosplenic T-cell lymphoma; Subcutaneous panniculitis-like T-cell lymphoma; Angioimmunoblastic T-cell lymphoma; Anaplastic large cell lymphoma-primary cutaneous type; and Blastic plasmacytoid dendritic cell neoplasm
  • by CT or MRI or PET/CT: Must have at least one lesion that has a single diameter of >= 2 cm or tumor cells in the blood >= 5 x10\^9/L (Skin lesions can be used if the area is >= 2 cm in at least one diameter and photographed with a ruler)
  • For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease is defined by both of the following criteria: Bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow and quantitative IgM monoclonal protein > 800 mg/dL
  • >= 1200/uL
  • > 9 g/dl
  • >= 50,000/uL
  • Total =\< 1.5 x (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be normal
  • =\< 2.5 x ULN or AST =\< 5 x ULN if liver involvement
  • Creatinine =\< 1.5 x ULN
  • >= 50mL/min (Cockcroft-Gault calculation)
  • Fasting serum cholesterol =\< 300 mg/dL OR =\< 7.75 mmol/L AND fasting triglycerides =\< 2.5 x ULN (NOTE: Lipid lowering medication is allowed)
  • Performance Status (PS) 0, 1, or 2
  • Females of (FCBP) must have a negative serum pregnancy test with a sensitivity of at least 50 IU/ml within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of , one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide, during study treatment and for 8 weeks after the last dose of RAD001 (FCBP must also agree to ongoing pregnancy testing)
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy (All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure)
  • Provide informed written consent
  • Willingness to return to Mayo Clinic enrolling institution for follow-up
  • Patient is willing to provide blood samples for research purposes
  • Recovered from acute side effects of prior myelosuppressive chemotherapy or biological therapy
  • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist

Exclusion criteria

Exclusion

  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Active other , excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer)
  • History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; Nursing women; Men or women of who are unwilling to employ adequate throughout the study and for 8 weeks after the last dose of study drug (NOTE: If barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception)
  • Patients who have received prior treatment with both an mTOR inhibitor (sirolimus, temsirolimus, everolimus) and lenalidomide who did not have a response to either when used as single agents
  • Patients with a known allergic reaction to thalidomide, RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or their to the point where either agent should not be given again
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Known positive for or infectious hepatitis, type A, B or C
  • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
  • Immunization with attenuated within one week of study entry or during study period
  • Uncontrolled brain or , including patients who continue to require for brain or leptomeningeal metastases
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Prior Stem Cell Transplant
  • No chronic treatment with systemic steroids or another agents (at a dose equivalent of greater than 20 mg prednisone per day) or other immunosuppressive agents)
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Arm I

    Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

    Drug: everolimus · Drug: lenalidomide · Other: laboratory biomarker analysis · Genetic: polymorphism analysis · Other: immunohistochemistry staining method · Genetic: microarray analysis · Genetic: fluorescence in situ hybridization

Interventions

  • Given orally

    Also known as: 42-O-(2-hydroxy)ethyl rapamycin, Afinitor, RAD001

  • Given orally

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

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Geneticpolymorphism analysis

    Correlative studies

  • Otherimmunohistochemistry staining method

    Optional correlative studies

    Also known as: immunohistochemistry

  • Geneticmicroarray analysis

    Optional correlative studies

    Also known as: gene expression profiling

  • Geneticfluorescence in situ hybridization

    Optional correlative studies

    Also known as: fluorescence in situ hybridization (FISH)

06

What researchers measure

Primary outcomes

  1. Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)

    The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported

    Time frame: After one 28 day cycle

  2. Best Response to Dose Level 0

    Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall Survival for All Eligible Patients

    Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Time frame: Up to 5 years

  2. Progression-Free Survival For All Eligible Patients

    Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.

    Time frame: Up to 5 years

  3. Duration of Response for All Eligible Patients

    Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented.

    Time frame: Up to 5 years

  4. Time to Treatment Failure for All Eligible Patients

    Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.

    Time frame: Up to 5 years

07

Results

Posted Mar 23, 2020

Participant flow

Participant flow — Overall Study
MilestonePhase I: Dose Level -1Phase I: Dose Level 0Phase I: Dose Level 1Phase II: Dose Level 0
Started79933
Completed69731
Not completed1022
Withdrew: Withdrawal by subject0011
Withdrew: Protocol violation0010
Withdrew: Treatment incomplete due to progression1000
Withdrew: Ineligible (miscalculated lab value)0001

Outcome measures

PrimaryNumber of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)

The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported

Time frame:
After one 28 day cycle
Reported as:
Count of participants · Participants
Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)
ParticipantsPhase I: Dose Level -1Phase I: Dose Level 0Phase I: Dose Level 1Phase II: Dose Level 0
Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)1230
PrimaryBest Response to Dose Level 0

Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Best Response to Dose Level 0
ParticipantsDose Level 0
Complete Response4
Partial Response8
Minor Response1
Stable Disease16
Progression12
SecondaryOverall Survival for All Eligible Patients

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Time frame:
Up to 5 years
Reported as:
Median · months
Overall Survival for All Eligible Patients
monthsAll Patients (Everolimus and Lenalidomide)
Overall Survival for All Eligible Patients20.3 (8.7 to 51.3)
SecondaryProgression-Free Survival For All Eligible Patients

Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.

Time frame:
Up to 5 years
Reported as:
Median · months
Progression-Free Survival For All Eligible Patients
monthsAll Patients (Everolimus and Lenalidomide)
Progression-Free Survival For All Eligible Patients5.3 (3.0 to 7.0)
SecondaryDuration of Response for All Eligible Patients

Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented.

Time frame:
Up to 5 years
Reported as:
Median · months
Duration of Response for All Eligible Patients
monthsAll Patients (Everolimus and Lenalidomide)
Duration of Response for All Eligible Patients14.7 (2.8 to 22.0)
SecondaryTime to Treatment Failure for All Eligible Patients

Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.

Time frame:
Up to 5 years
Reported as:
Median · months
Time to Treatment Failure for All Eligible Patients
monthsAll Patients (Everolimus and Lenalidomide)
Time to Treatment Failure for All Eligible Patients4.7 (2.2 to 6.6)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I: Dose Level -16/7 (85.7%)3/7 (42.9%)6/7 (85.7%)
Phase I: Dose Level 06/9 (66.7%)7/9 (77.8%)9/9 (100%)
Phase I: Dose Level 17/8 (87.5%)5/7 (71.4%)7/7 (100%)
Phase II: Dose Level 018/32 (56.3%)14/32 (43.8%)32/32 (100%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventPhase I: Dose Level -1Phase I: Dose Level 0Phase I: Dose Level 1Phase II: Dose Level 0
Lung infectionInfections and infestations1/73/90/70/32
Neutrophil count decreasedInvestigations1/73/92/75/32
White blood cell decreasedInvestigations1/73/91/73/32
FatigueGeneral disorders2/70/91/71/32
SepsisInfections and infestations0/70/92/71/32
Platelet count decreasedInvestigations1/72/91/73/32
Febrile neutropeniaBlood and lymphatic system disorders0/70/91/71/32
ColitisGastrointestinal disorders0/70/91/70/32
Mucositis oralGastrointestinal disorders0/70/91/70/32
Edema limbsGeneral disorders1/70/90/70/32
Most frequent other events
Showing 10 of 63
Most frequent other events
EventPhase I: Dose Level -1Phase I: Dose Level 0Phase I: Dose Level 1Phase II: Dose Level 0
FatigueGeneral disorders6/77/97/727/32
Platelet count decreasedInvestigations3/79/95/723/32
Neutrophil count decreasedInvestigations3/78/94/725/32
White blood cell decreasedInvestigations4/78/96/726/32
CoughRespiratory, thoracic and mediastinal disorders4/76/95/723/32
DyspneaRespiratory, thoracic and mediastinal disorders5/76/92/717/32
DiarrheaGastrointestinal disorders3/76/90/717/32
NauseaGastrointestinal disorders3/74/94/717/32
Rash acneiformSkin and subcutaneous tissue disorders4/72/93/718/32
Edema limbsGeneral disorders3/75/92/713/32

Baseline characteristics

Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.

Age, Continuous
Age, Continuous(years)All Patients (Everolimus and Lenalidomide)
Median62 (21 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)All Patients (Everolimus and Lenalidomide)
Female17
Male38
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Patients (Everolimus and Lenalidomide)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White54
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Patients (Everolimus and Lenalidomide)
United States55
08

Study locations

2 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2011 to primary completion in Feb 2015, 49 months.

Results were first posted in Mar 2020, 5 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2010
First posted
Feb 25, 2010
StartActual
Jan 10, 2011
Primary completionActual
Feb 28, 2015
CompletionActual
Feb 13, 2020
Results first posted
Mar 23, 2020
Last update
Oct 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01075321
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Feb 25, 2010
Start date
Jan 10, 2011
Primary completion
Feb 28, 2015
Completion
Feb 13, 2020
Results posted
Mar 23, 2020
Last update
Oct 22, 2020

Study contacts

Craig Reeder, M.D.
study chair · Mayo Clinic
Thomas E. Witzig, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Everolimus · Lenalidomide

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