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Multiple MyelomaPhase 2RADNCT02471820

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

A Phase 2 study testing Lenalidomide, Adriamycin and Dexamethasone in people with Multiple Myeloma, run by Meletios A. Dimopoulos at 4 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Lenalidomide, Adriamycin and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
4 sitesGreece
Study dates
Nov 2014to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

Greece4 sites

  • General Hospital of Athens "G. Gennimatas"

    Athens, Attica, 11527

  • General Hospital of Athens "Alexandra"

    Athens, Attica, 11528

  • University General Hospital of Patras

    Pátrai, Patra, 26504

  • Theageneio Anticancer Hospital of Thessaloniki

    Thessaloniki, Thessaloniki, 54007

Other trials in Greece

About this study

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

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.

Read the detailed description

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.

Being tested
Lenalidomide, Adriamycin, Dexamethasone
Keywords
Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Combination of Lenalidomide, adriamycin & dexamethasone

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

  • AdriamycinDrug

    Also called Combination of Lenalidomide, adriamycin & dexamethasone

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

  • DexamethasoneDrug

    Also called Combination of Lenalidomide, adriamycin & 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

Study groups in NCT02471820
Study groupRoleWhat they receive
Lenalidomide, adriamycin & dexamethasoneExperimentalLenalidomide 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
Receives: Drug: Lenalidomide; Drug: Adriamycin; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 142 days

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    Measured: 142 days

  2. Time to progression (TTP)

    Measured: 142 days

  3. Time to Next Therapy (TtNT)

    Measured: 142 days

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

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

    Measured: 142 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02471820
Sponsor's protocol ID
RV-MM-GMSG-392
Other IDs
2011-001499-20
Acronym
RAD
Status last verified
Oct 2016
First submitted
5 Jun 2015
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide, Adriamycin and Dexamethasone in people with Multiple Myeloma, run by Meletios A. Dimopoulos at 4 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 142 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02471820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.

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