Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

This study has been completed.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: October 22, 2008
Last updated: May 12, 2015
Last verified: May 2015
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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-finding Study of Lenalidomide as Maintenance Therapy in Multiple Myeloma After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

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 ]

Enrollment: 24
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00778752

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

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00778752     History of Changes
Other Study ID Numbers: Revlimid as maintenance in MM
Study First Received: October 22, 2008
Last Updated: May 12, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Myeloma
Stem Cell Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015