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Sponsored by: |
King's College Hospital NHS Trust |
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Information provided by: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT00915408 |
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 | Intervention | Phase |
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Multiple Myeloma |
Drug: Lenalidomide Drug: Dexamethasone Drug: Cyclophosphamide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 32 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CRD: Experimental |
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.
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities:
United Kingdom | |
King's College Hospital NHS Foundation Trust | |
London, United Kingdom, SE5 9RS | |
Royal Marsden NHS Foundation Trust | |
London, United Kingdom, SM2 5PT |
Principal Investigator: | Steve Schey, FRCP FRACP FRCPath | King's College Hospital NHS Foundation Trust |
Responsible Party: | King's College Hospital NHS Foundation Trust ( Dr Steve Schey ) |
Study ID Numbers: | 05CC15, REC - 06/Q1606/75, EudraCT - 2005-005145-19 |
Study First Received: | June 5, 2009 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00915408 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Multiple Myeloma Cyclophosphamide Dexamethasone Lenalidomide |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Immunosuppressive Agents Glucocorticoids Multiple Myeloma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses |
Cardiovascular Diseases Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents Vascular Diseases Lenalidomide Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma |