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Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778752
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Revlimid (Lenalidomide) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation
Study Start Date : April 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: A

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.

Primary Outcome Measures :
  1. Maximal tolerable dose of lenalidomide after allogeneic stem cell transplantation in patients with multiple myeloma [ Time Frame: 2 years post-transplantation ]

Secondary Outcome Measures :
  1. Determination of remission status after lenalidomide treatment [ Time Frame: 2 years post-transplantation ]
  2. Effect on T-cell/ NK-cell recovery [ Time Frame: 1 year post-transplantation ]
  3. Incidence of infectious complications and GvHD [ Time Frame: 1 year post-transplantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00778752

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Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00778752     History of Changes
Other Study ID Numbers: Revlimid as maintenance in MM
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Myeloma
Stem Cell Transplantation
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Multiple Myeloma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents