Dose-Finding of Lenalidomide as Maintenance in Multiple Myeloma - Full Text View

Sponsored by:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00778752

Purpose

This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).

Condition	Intervention	Phase
Multiple Myeloma	Drug: Revlimid (Lenalidomide)	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dose-Finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:

Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma [ Time Frame: 2 years post-transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determination of remission status after lenalidomide treatment [ Time Frame: 2 years post-transplantation ] [ Designated as safety issue: Yes ]
Effect on T-cell/ NK-cell recovery [ Time Frame: 1 year post-transplantation ] [ Designated as safety issue: Yes ]
Incidence of infectious complications and GvHD [ Time Frame: 1 year post-transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated. Dose-level -1: 2.5 mg/d if 2.5mg capsules are available, day 1-21, otherwise 5 mg every other day, day 1-21 Dose-level 0: 5 mg/d, day 1-21 Dose-level 1: 10 mg/d, day 1-21 Dose-level 2: 15 mg/d, day 1-21	Drug: Revlimid (Lenalidomide) 3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall. If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall. If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials.

Arms

Assigned Interventions

A: Experimental

Lenalidomide-treatment starts between 100 and 180 days after allogeneic stem cell transplantation. Three dose-levels will be investigated.

Dose-level -1: 2.5 mg/d if 2.5mg capsules are available, day 1-21, otherwise 5 mg every other day, day 1-21
Dose-level 0: 5 mg/d, day 1-21
Dose-level 1: 10 mg/d, day 1-21
Dose-level 2: 15 mg/d, day 1-21

Drug: Revlimid (Lenalidomide)

3 pat. will be enrolled on dose level 0. If no DLTs are observed during cycles 1+2 dose will be escalated to the next higher level in the 3 patients. If 1 of 3 pat. experiences DLT at the current dose, then up to 3 more pat. will be accrued at the same level. If none of these 3 additional pat. experience DLT dose will be escalated in subsequent patients. If 1 of these 3 patients experiences DLT, the next lower level will be declared to be MTD and the study will be filled up with patients at this dose level up to 25 pat. overall.

If 2 or more of 3 pat. or 3 or more of 6 pat. in the same cohort encounter DLT, the MTD has been exceeded and the previous lower dose level will be declared as MTD and the study will be filled up with patients at this level up to 25 pat. overall.

If DLT is observed in level 0, the next dose level will be -1 for the following cohort of 3 patients. If level 2 is well tolerated without DLT, this level will be claimed as recommended dose for further trials.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Understand and voluntarily sign informed consent form
Age > 18 years at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)
No active acute GvHD (grade II - IV)
No active infectious complications
ECOG performance status of < 2 at study entry
Laboratory test results within these ranges:
- Absolute WBC count > 3.0 x 10^9/l
- Platelet count > 80 x 10^9/l
- Serum creatinine < 1.5 mg/dl
- Total bilirubin < 1,5 mg/dl
- AST (SGOT) and ALT (SGPT) < 3 x ULN
Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study and at least 28 days after discontinuation from the study.
male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days after discontinuation of study drug
disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
pregnant or breast feeding females
use of any other experimental drug or therapy within 28 days of baseline
known hypersensitivity to thalidomide
concurrent use of other anti-cancer agents or treatments
known positive for HIV of infectious hepatitis, type A, B, or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778752

Contacts

Contact: Nicolaus Kroeger, Prof. Dr.	+49-40-42803-5864	nkroeger@uke.uni-hamburg.de
Contact: Marion Heinzelmann, R.N.	+49-40-42803-4188	mheinzel@uke.uni-hamburg.de

Locations

Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator:

Nicolaus Kroeger, Prof. Dr.

University Medical Center Hamburg-Eppendorf, Germany

More Information

Responsible Party:	Universitätsklinikum Hamburg-Eppendorf ( Prof. N. Kroeger )
Study ID Numbers:	Revlimid as maintenance in MM
Study First Received:	October 22, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00778752
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

Multiple Myeloma
Stem Cell Transplantation
Revlimid
Lenalidomide

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Signs and Symptoms
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009