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A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma (CRD)

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: NCT00915408
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : September 2, 2015
Information provided by:
King's College Hospital NHS Trust

Brief Summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in patients who present with relapsed or refractory myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Drug: Cyclophosphamide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma
Study Start Date : September 2006
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: CRD Drug: Lenalidomide
Oral lenalidomide 25mg daily on Days 1-21 every 28 days cycles for up to 9 cycles. From Cycle 10 Lenalidomide 25mg orally on days 1-21, every 28 days.
Other Name: Revlimid

Drug: Dexamethasone
Dexamethasone 20mgs orally, daily on Days 1-4 and 8-11 repeated every 28 day cycles for up to 9 cycles.

Drug: Cyclophosphamide
Oral Cyclophosphamide will be added to the regime starting on days 1 and 8. The dose of Cyclophosphamide will be escalated in cohorts rising in 100mg increments from 300 to 700mgs days 1,and 8 every 28 day cycles for up to 9 cycles.

Primary Outcome Measures :
  1. Dose limiting toxicity defined as: a) NCI Grade 4 haematological toxicity b) NCI Grade ¾ non-haematological toxicity [ Time Frame: Weekly for first cycle ]
  2. Safety (type, frequency, severity, and relationship of adverse events) [ Time Frame: Weekly for first cycle then monthly ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Monthly ]
  2. Paraprotein response [ Time Frame: Monthly ]
  3. Bone marrow response [ Time Frame: Baseline, end of treatment and disease progression ]
  4. Duration of response [ Time Frame: Monthly ]
  5. Overall survival [ Time Frame: Monthly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >18 years at the time of signing the informed consent form.
  3. Proven diagnosis of multiple myeloma.
  4. Relapse or Refractory disease with evidence of progression after at least 2 cycles of anti-myeloma treatment.
  5. Relapse or refractory disease with evidence of progressive disease after at least 1 previous therapy this may include consolidation of induction with a stem cell transplant).
  6. Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) must be complete prior to the initiation of therapy. The initiation of radiation therapy after baseline (Day 1) will be considered to be a treatment failure (except when given to treat or to promote the healing of a pathological fracture).
  7. Measurable levels of myeloma paraprotein in serum (>5 gms/L) or urine > 2 g excreted in a 24-hour collection sample).
  8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  9. Able to adhere to the study visit schedule and other protocol requirements.
  10. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting study drug. In addition, sexually active WCBP must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy. WCBP must agree to have pregnancy tests weekly for the first 4 weeks, then monthly while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy.
  11. Disease free of prior malignancies for equal to or over 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast.
  12. Able to receive low dose aspirin (e.g. 75mg) as prophylactic anticoagulant medication to prevent thromboembolism unless contraindicated. If low dose aspirin is contraindicated, subjects will receive another form of anticoagulant prophylaxis according to hospital guidelines.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or lactating females.
  3. Any of the following laboratory abnormalities:

    1. Absolute neutrophil count (ANC) <1.000 cells/mm3 (1.0 x 109/L)
    2. Platelet count <.75.000/mm3 (75 x 109L)
    3. Serum creatinine >2.5 mg/dL (221 umol/L)
    4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
    5. Serum total bilirubin >2.0 mg/dL (34 umol/L)
  4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  5. Known hypersensitivity to thalidomide, dexamethasone or cyclophosphamide.
  6. Prior history of uncontrollable side effects to dexamethasone therapy
  7. The development of a desquamating rash while taking thalidomide
  8. Any prior use of Lenalidomide (Revlimid®)
  9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of entry or use of any experimental non-drug therapy (e.g. donor leukocyte/mononuclear cell infusions) within 56 days of entry.

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): NCT00915408

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United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Royal Marsden NHS Foundation Trust
London, United Kingdom, SM2 5PT
Sponsors and Collaborators
King's College Hospital NHS Trust
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Principal Investigator: Steve Schey, FRCP FRACP FRCPath King's College Hospital NHS Trust
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Responsible Party: Dr Steve Schey, King's College Hospital NHS Foundation Trust Identifier: NCT00915408    
Other Study ID Numbers: 05CC15
REC - 06/Q1606/75
EudraCT - 2005-005145-19
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: April 2013
Keywords provided by King's College Hospital NHS Trust:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents