Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients
RAD
Phase II Open Label Study for the Assessment of the Efficacy and Safety of Lenalidomide & Adriamycin & Low Dose Dexamethasone (RAD) in Newly Diagnosed, Symptomatic Multiple Myeloma Patients
2 other identifiers
interventional
45
1 country
4
Brief Summary
This study is to assess the efficacy and safety of lenalidomide in combination with adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Nov 2014
Shorter than P25 for phase_2 multiple-myeloma
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 17, 2016
October 1, 2016
1.7 years
June 5, 2015
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Assessment of the overall response rate of study population to RAD regimen (including stringent complete response, complete response, very good partial response, partial response and stable disease) according to the uniform criteria of IMWG (International Myeloma Working Group) regarding the response to multiple myeloma therapy
142 days
Secondary Outcomes (4)
Progression-free survival (PFS)
142 days
Time to progression (TTP)
142 days
Time to Next Therapy (TtNT)
142 days
Number and severity of Adverse events as a measure of safety and toxicity profile
142 days
Other Outcomes (31)
Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT)
142 days
Dickkopf-1 (DKK-1)
1 day
Dickkopf-1 (DKK-1)
112 days
- +28 more other outcomes
Study Arms (1)
Lenalidomide, adriamycin & dexamethasone
EXPERIMENTALLenalidomide 25 mg administered orally for the first 21 days of each 28-day-cycle, plus Adriamycin i.v. on days 1,2,3 \& 4 of every cycle, plus Dexamethasone 40 mg orally on days 1, 8, 15 \& 22 of every cycle for 4 cycles
Interventions
Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles
Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles
Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles
Eligibility Criteria
You may qualify if:
- Subjects able to read and understand the Informed Consent Form (ICF).
- Subjects willing to participate in the study and comply with its procedures.
- Subjects who have signed the ICF
- Newly diagnosed patients with symptomatic MM according to the criteria of IMWG
- Subjects eligible for autologous stem cell transplantation
- Age 18-70 years, of either sex
- karnofsky ≥ 60
- Platelets ≥ 100x109/L
- Neutrophils ≥ 1.5x109/L
- Alanine transaminase (ALT) \& Aspartate transaminase (AST) ≤ 3-fold of upper normal limit
- Bilirubin ≤ 2-fold of upper normal limit
- Creatinine clearance ≥60 ml/min
- Expected survival ≥ 6 months as per PI's clinical judgment
- Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation
- Female subject of childbearing potential must have 2 negative serum pregnancy tests (hCG) at Screening (once within 10-14 days and once 24 h before the study drug administration) and if sexually active must be using two medically acceptable, highly effective, adequate forms of birth control (ie, failure rate \<1% per year when used consistently and correctly) prior to Screening and and for time period at least 28 days before the study drug administration and agree to continue using it while being in the study (Screening and Treatment Periods including dose interruptions). A female subject should continue using a highly effective method of birth control for 30 days following the end of treatment.
- +2 more criteria
You may not qualify if:
- Pregnancy, breastfeeding οr intention of pregnancy during the trial
- Suspected or known hypersensitivity to any of the study drugs
- Ongoing severe infection requiring intravenous antibiotic treatment
- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Uncontrolled medical problems such as diabetes, coronary artery disease, hypertension, unstable angina, arrhythmia, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to MM
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study
- Subjects with any clinical condition that would affect study's outcome
- Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study, except of the clinical trials that implicate drugs of supportive treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
General Hospital of Athens "G. Gennimatas"
Athens, Attica, 11527, Greece
General Hospital of Athens "Alexandra"
Athens, Attica, 11528, Greece
University General Hospital of Patras
Pátrai, Patra, 26504, Greece
Theageneio Anticancer Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 54007, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meletios Dimopoulos, Doctor
General Hospital of Athens "Alexandra"
- PRINCIPAL INVESTIGATOR
Eirini Katodritou, Doctor
Theageneio Anticancer Hospital of Thessaloniki
- PRINCIPAL INVESTIGATOR
Nikolaos Anagnostopoulos, Doctor
General Hospital of Athens "G. Gennimatas''
- PRINCIPAL INVESTIGATOR
Argirios Symeonidis, Doctor
University General Hospital of Patras
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Department of Clinical Therapeutics University of Athens School of Medicine
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 15, 2015
Study Start
November 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 17, 2016
Record last verified: 2016-10