Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients (RAD)
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ClinicalTrials.gov Identifier: NCT02471820 |
Recruitment Status :
Completed
First Posted : June 15, 2015
Last Update Posted : October 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: Lenalidomide Drug: Adriamycin Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | November 2014 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
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Experimental: Lenalidomide, adriamycin & dexamethasone
Lenalidomide 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
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Drug: Lenalidomide
Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles
Other Name: Combination of Lenalidomide, adriamycin & dexamethasone Drug: Adriamycin 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 Name: Combination of Lenalidomide, adriamycin & dexamethasone Drug: Dexamethasone 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 Name: Combination of Lenalidomide, adriamycin & dexamethasone |
- 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
- Progression-free survival (PFS) [ Time Frame: 142 days ]
- Time to progression (TTP) [ Time Frame: 142 days ]
- Time to Next Therapy (TtNT) [ Time Frame: 142 days ]
- 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)
- Number of stem cell collected before Autologous Stem Cell Transplantation (ASCT) [ Time Frame: 142 days ]
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT02471820
Greece | |
General Hospital of Athens "G. Gennimatas" | |
Athens, Attica, Greece, 11527 | |
General Hospital of Athens "Alexandra" | |
Athens, Attica, Greece, 11528 | |
University General Hospital of Patras | |
Patra, Greece, 26504 | |
Theageneio Anticancer Hospital of Thessaloniki | |
Thessaloniki, Greece, 54007 |
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 |
Responsible Party: | Meletios A. Dimopoulos, Professor of Department of Clinical Therapeutics University of Athens School of Medicine, University of Athens |
ClinicalTrials.gov Identifier: | NCT02471820 |
Other Study ID Numbers: |
RV-MM-GMSG-392 2011-001499-20 ( EudraCT Number ) |
First Posted: | June 15, 2015 Key Record Dates |
Last Update Posted: | October 17, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Multiple Myeloma |
Dexamethasone Dexamethasone acetate Lenalidomide BB 1101 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 Doxorubicin Liposomal doxorubicin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |