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Trial record 95 of 491 for:    LENALIDOMIDE AND every 28 days

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00540644
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Attaya Suvannasankha, Indiana University School of Medicine

Brief Summary:
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: lenalidomide (Revlimid®) Drug: Cyclophosphamide Drug: Prednisone Phase 2

Detailed Description:
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
Study Start Date : October 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Experimental: Revlimid, Cyclophosphamide, Prednisone

Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Prednisone every other day orally.

Drug: lenalidomide (Revlimid®)
25 mg p.o. daily on days 1-21 of each 28 day cycle
Other Name: Revlimid®

Drug: Cyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycle

Drug: Prednisone
50 mg p.o. Q.O.D.




Primary Outcome Measures :
  1. Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria [ Time Frame: After 6 cycles ]
    Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.


Secondary Outcome Measures :
  1. Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: Beginning of treatment up to 5 years ]
    Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

  2. Quality of Life Using the FACT-G Data [ Time Frame: baseline and after last cycle (up to 6 cycles) ]

    Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.

    Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome




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

Inclusion Criteria:

Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:

  • Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma

PLUS one or more of the following:

  • Calcium elevation (11.5 mg/dl) [42.65 mmol/l]
  • Renal insufficiency (1.5 x the ULN of serum creatinine)
  • Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal)
  • Bone disease (lytic lesions or osteopenia)

Measurable disease is defined at least one of the following three measurements:

  • Serum M-protein >=1 g/dl ( or 10 g/l)
  • Urine M-protein >=200 mg/24 h
  • Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal
  • Measurable plasmacytoma
  • NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response.

Laboratory test results within these ranges:

  • Absolute neutrophil count >= 1.0 x 109/L
  • Platelet count >= 50 x 10(9)/L
  • Hemoglobin >= 9 gm/dl
  • Serum creatinine <= 2.5mg/dL.
  • Total bilirubin <=1.5 x upper limit of normal
  • AST (SGOT) and ALT (SGPT) <= 3 x ULN

Exclusion Criteria:

  • Known hypersensitivity to thalidomide
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Patients with a solitary plasmacytoma
  • Patients with uncontrolled diabetes
  • Patients with ≥ Grade 3 sensory neuropathy
  • History of cardiac disease, with NYHA Class II or greater

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 ClinicalTrials.gov identifier (NCT number): NCT00540644


Locations
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United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Attaya Suvannasankha
Celgene
Investigators
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Principal Investigator: Attaya Suvannasankha, M.D. Indiana University School of Medicine

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Responsible Party: Attaya Suvannasankha, Assistant Professor of Medicine, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00540644     History of Changes
Other Study ID Numbers: 0704-06; IUCRO-0170
First Posted: October 8, 2007    Key Record Dates
Results First Posted: June 21, 2016
Last Update Posted: June 21, 2016
Last Verified: May 2016
Keywords provided by Attaya Suvannasankha, Indiana University School of Medicine:
Multiple Myeloma
Revlimid
Additional relevant MeSH terms:
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Lenalidomide
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists