Skip to main content
OpenTrials
Completed

NCT Number: NCT02471820

Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General Hospital of Athens "Alexandra", Athens, Attica, Greece

Loading trial locations.

About this study

This is a Phase II, non randomized, non- comparative, open label trial which assess the efficacy and safety of lenalidomide, adriamycin and low dose dexamethasone combination (RAD) in 45 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. The recruitment period is estimated for 5 months while the treatment period and the follow up period 4 months and 1 month respectively. During the treatment initiation visit the response to the combination RAD according the International Myeloma Working Group (IMWG) criteria will be evaluated, biochemical markers of bone metabolism and angiogenic cytokines will be measured as well. IMWG Response evaluation will be repeated the day 1 of each treatment cycle as well as at the response evaluation visit. Finally biochemical markers of bone metabolism and angiogenic cytokines will be measured once more at the end of treatment visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • A male subject must agree to use an adequate form of contraception for the duration of the study, while taking the study drug, during dose interruptions at for at least 28 days after the last dose of study drug even if he has had a successful vasectomy and agree to have sexual relations only with women who use a highly effective birth control method.
  • Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations

Exclusion criteria

  • 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
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the Prostatic specific antigen (PSA) has been stable for 3 years
  • 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

Treatment and study plan

Lenalidomide

Drug

Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles

Other names: Combination of Lenalidomide, adriamycin & dexamethasone

Adriamycin

Drug

Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles

Other names: Combination of Lenalidomide, adriamycin & dexamethasone

Dexamethasone

Drug

Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles

Other names: Combination of Lenalidomide, adriamycin & dexamethasone

Primary outcomes

  1. Overall response rate

    Time frame: 142 days

    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

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 142 days

  2. Time to progression (TTP)

    Time frame: 142 days

  3. Time to Next Therapy (TtNT)

    Time frame: 142 days

  4. Number and severity of Adverse events as a measure of safety and toxicity profile

    Time frame: 142 days

    Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 2.0)

Other outcomes

  1. Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT)

    Time frame: 142 days

  2. Dickkopf-1 (DKK-1)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  3. Dickkopf-1 (DKK-1)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  4. C-telopeptide of type-I collagen (CTX)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  5. C-telopeptide of type-I collagen (CTX)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  6. Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)

    Time frame: 1 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  7. Tartrate-resistant acid phosphatase isoform-5b (TRACP-5b)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  8. Bone-alkaline phosphatase (bALP)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  9. Bone-alkaline phosphatase (bALP)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  10. Osteocalcin (OC)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  11. Osteocalcin (OC)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  12. C-terminal propeptide of procollagen type-I (CICP)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  13. C-terminal propeptide of procollagen type-I (CICP)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  14. Soluble and total RANKL (sRANKL, tRANKL)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  15. Soluble and total RANKL (sRANKL, tRANKL)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  16. Osteoprotegerin (OPG)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  17. Osteoprotegerin (OPG)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  18. Osteopontin (OPN)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  19. Osteopontin (OPN)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  20. Macrophage inflammatory protein 1-alpha (MIP-1α)

    Time frame: 1 day

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  21. Macrophage inflammatory protein 1-alpha (MIP-1α)

    Time frame: 112 days

    Biochemical markers of bone remodeling will be measured in the serum of patients at therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  22. Angiopoietin-1 & -2

    Time frame: 1 day

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  23. Angiopoietin-1 & -2

    Time frame: 112 days

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  24. Angiogenin

    Time frame: 1 day

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  25. Angiogenin

    Time frame: 112 days

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  26. VEGF

    Time frame: 1 day

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  27. Vascular endothelial growth factor (VEGF)

    Time frame: 112 days

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  28. VEGF-A

    Time frame: 1 day

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  29. VEGF-A

    Time frame: 112 days

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  30. basic fibroblast growth factor (bFGF)

    Time frame: 1 day

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

  31. basic fibroblast growth factor (bFGF)

    Time frame: 112 days

    Angiogenic cytokines, which will be evaluated in the serum of patients during therapy commencement on Day 1 of cycle 1 and at therapy completion on day 28 of cycle 4. 28-days-cycle

Sponsors and collaborators

Lead sponsor

Meletios A. Dimopoulos

Other

Registry information

Official study title

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

Acronym: RAD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.