NCT00729638

Brief Summary

The purpose of this research study is to determine the highest dose of lenalidomide and RAD001 that can be given without causing too many serious side effects. Another goal of this research study is to look at how the participants cancer may respond to the study treatment. Additionally, we wish to learn more about how the body breaks down and gets rid of the study drugs. We will also try to find substances in the blood (biomarkers) that may help predict how myeloma will respond to study treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

August 4, 2008

Last Update Submit

August 7, 2014

Conditions

Multiple Myeloma

Keywords

relapsed multiple myelomarefractory multiple myelomaRAD001lenalidomide

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety of RAD001 when given in combination with lenalidomide and to identify the maximum tolerated dose (MTD) as well as a recommended Phase 2 dose for the combination in this patient population.

    2 years

Secondary Outcomes (3)

  • To evaluate the response to the combination of RAD001 and lenalidomide in subjects with multiple myeloma.

    2 years

  • To determine the pharmacokinetics of RAD001 and lenalidomide.

    2 years

  • To identify possible surrogate markers to better define mechanisms of action for the combination of the two drugs.

    2 years

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm phase I study

Drug: RAD001Drug: lenalidomide

Interventions

RAD001DRUG

Dose levels will change: Taken orally either every other day for the first three weeks of each cycle or taken every day for the first three weeks of each cycle.

Single arm
lenalidomideDRUG

Dose level will vary: taken orally 30-60 minutes after taking RAD001 every day for the first three weeks of each cycle.

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject was previously diagnosed with multiple myeloma bases on standard criteria listed in protocol
  • Patients must have relapsed or relapsed/refractory disease
  • years of age or older
  • All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment
  • ECOG Performance Status of 0 to 2
  • Able to take aspirin (81 or 325mg) daily as prophylactic anticoagulation
  • Prior thalidomide/lenalidomide therapy is allowed
  • Able to take bactrim
  • Female of childbearing potential must have a negative serum or urine pregnancy test

You may not qualify if:

  • Renal insufficiency
  • Concommitant therapy medications that include corticosteroids or other chemotherapy that is or may be active against myeloma or therapy with chemotherapy within 2 weeks prior to day 1. Nitrosoureas must be discontinued 6 weeks prior to day 1. Concurrent radiation therapy is not permitted.
  • Subjects with evidence of mucosal or internal bleeding and/or platelet refractory
  • Subjects with poorly controlled diabetes mellitus
  • Subjects with an ANC \< 10-00 cells/mm3
  • Subjects with a hemoglobin \< 8.0 g/Dl
  • AST (SGOT and ALT (SGPT) greater or equal to 2x ULN
  • Prior therapy with RAD001
  • Known hypersensitivity to thalidomide or lenalidomide
  • Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study
  • Clinically relevant active infection or serious co-morbid medical conditions such as recent thromboembolic disease are ineligible if occurred less than 2 weeks prior to enrollment or clinically unstable
  • Chronic obstructive or chronic restrictive pulmonary disease, difficult to control diabetes, upper gastrointestinal ulceration, and cirrhosis
  • Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or other cancer for which the subject has been disease-free for at least 3 years
  • Pregnant or breast-feeding females
  • Prior treatment with any investigational drug within preceding 4 weeks
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226', United States

Location

Related Publications (1)

  • Yee AJ, Hari P, Marcheselli R, Mahindra AK, Cirstea DD, Scullen TA, Burke JN, Rodig SJ, Hideshima T, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Weller EA, Richardson PG, Raje NS. Outcomes in patients with relapsed or refractory multiple myeloma in a phase I study of everolimus in combination with lenalidomide. Br J Haematol. 2014 Aug;166(3):401-9. doi: 10.1111/bjh.12909. Epub 2014 Apr 25.

    PMID: 24761838RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

EverolimusLenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Noopur Raje, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Multiple Myeloma

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(5)