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Multiple MyelomaPhase 1/2NCT01355705

Phase 1-2 Amrubicin in Combo With Lenalidomide + Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Amrubicin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Michaela Liedtke at 1 site in United States.

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

To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Amrubicin, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Aug 2011to Jul 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory multiple myeloma that has progressed following at least 1 prior therapy.
  • Measurable disease defined as one of the following:
  • Serum M-protein ≥ 1 g/dL
  • Urine M-protein ≥ 200 mg/24 hours
  • Received at least 1 prior line of systemic treatment that may have included lenalidomide and/or an anthracycline.
  • No cytotoxic chemotherapy within 4 weeks prior to first dose of amrubicin. This interval may be reduced to 14 days for thalidomide, lenalidomide, bortezomib or corticosteroids, provided other entry criteria are met.
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  • Age ≥ 18 at the time of consent.
  • Life expectancy of more than ≥ 3 months.
  • No known central nervous system involvement by myeloma.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at study registration during phase 1. Once safety is confirmed, ECOG performance status 0 to 2 at study registration during phase 2.
  • No poorly-controlled intercurrent illness.
  • Platelets > 100 x 10^9/L
  • Hemoglobin > 8.0g/dL
  • Absolute neutrophil count (ANC) >1.5 x 10^9/L
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN
  • Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula.
  • Left ventricular ejection fraction (LVEF) ≥ 50% by Echocardiogram (ECHO) or multiple gate acquisition scan (MUGA)
  • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the Requirements of RevAssist.
  • Disease-free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 U/mL within 10 to 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Able to take aspirin (81 or ≥ 25 mg) daily as prophylactic anticoagulation. Patients intolerant to aspirin may use warfarin or low molecular weight heparin (LMWH). Patients with previous thromboembolic event on lenalidomide or thalidomide may be started on warfarin or LMWH. Patients already taking warfarin or LMWH do not require additional aspirin..
  • Lactating females must agree not to breast-feed while taking lenalidomide

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breastfeeding females.
  • Any concurrent severe or uncontrolled medical disease which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of first dose of amrubicin.
  • Known hypersensitivity to thalidomide or lenalidomide.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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  • LVEF ≤ 50%.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV, or infectious hepatitis, type B or C.
  • Cranial radiotherapy ≤ 21 days prior to first dose of amrubicin; radiotherapy to all other areas ≤ 7 days prior to first dose of amrubicin.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 1 Study of Amrubicin in Combination With Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma

To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.

Read the detailed description

PRIMARY OBJECTIVES

  • Establish the maximum tolerated dose (MTD) and toxicity profile for the combination of amrubicin with lenalidomide and dexamethasone in previously treated adult patients with multiple myeloma during Phase I
  • Determine the combined rate of complete response (CR) and very good partial response (VGPR) for this combination in this population as defined by the International Myeloma Working Group Uniform Response Criteria (IMWGURC)

SECONDARY OBJECTIVES

  • Determine the overall response rate (CR, VGPR and PR)
  • Assess additional evidence of ant-tumor activity as measured by duration of response (DOR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS)
Being tested
Amrubicin, Lenalidomide, Dexamethasone, Aspirin, Pegfilgrastim
Medical subject headings
Multiple Myeloma

What participants receive

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

  • AmrubicinDrug

    Also called SM-5887

    40, 60, or 80 mg/m2 intravenous (IV)

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    15 mg daily by mouth

  • DexamethasoneDrug

    Also called Decadron, Dexamethasone Intensol, Dexpak Taperpak

    40 mg weekly by mouth

  • AspirinDrug

    Also called acetylsalicylic acid

    81 or 325 mg daily by mouth

  • PegfilgrastimDrug

    Also called Neulasta, PEG-GCSF

    6 mg subcutaneous on Day 2

Study groups in NCT01355705
Study groupRoleWhat they receive
Amrubicin + Lenalidomide + DexamethasoneExperimentalAmrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles. Concurrent therapeutic medications: * Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14 * Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15) Other drugs: * Aspirin: 81 or 325 mg daily oral * Pegfilgrastim subcutaneous on Day 2
Receives: Drug: Amrubicin; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Aspirin; Drug: Pegfilgrastim

What is being measured

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

  1. Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria

    Modified International Myeloma Working Group Uniform Response Criteria:

    Complete (CR)=

    • Negative for monoclonal protein (MP) in urine (U) and serum (S) +
    • No tissue plasmacytomas (PC) +
    • <5% plasma cells (PCs) in marrow (M)

    Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M

    Near CR (nCR)= CR, except MP persists in U and S

    Partial (PR)= S MP ≤50%, + U MP ≤90% or <200 mg/24 hours (hr)

    Very Good PR (VGPR)= in S MP ≤90%, + U MP <100 mg/24 hr

    Minimal (MR)=

    • S MP ≤51-75%, +
    • If light chain is excreted, reduced 50-89%/24 hr that is also >200 mg/24 hr, +
    • No increase in lytic bone lesions

    Progressive disease (PD)= any of:

    • S MP ≥125% and/or ≥+0.5 g/dL,
    • U MP ≥125% and/or ≥+200 mg/24 hr
    • New or increased bone lesions/PC
    • S calcium >11.5 mg/dL (attributed to increased PCs)

    PD after CR/sCR=

    • Reappearance of S or U MP
    • ≥5% clonal PCs in M
    • New PC, lytic bone lesions, hypercalcemia

    Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD

    Measured: 12 weeks

Secondary outcomes (3)

  1. Duration of Response (DOR)

    Measured: 140 days

  2. Progression-free Survival (PFS)

    Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:

    • Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,
    • Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline
    • New or increased bone lesions or plasmacytomas
    • Serum calcium > 11.5 mg/dL (attributed to increased plasma cells)

    Measured: 9 months

  3. Time-to-next Treatment

    Measured: 9 months

Timeline

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

  1. First posted18 May 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2016
  4. Study completionJul 2017

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355705
Sponsor's protocol ID
IRB-19092
Other IDs
AR_MM_PI_007, SU-05062011-7711, HEMMYL0018, IRB-19092
Status last verified
Sep 2018
First submitted
16 May 2011
Last updated
18 Sep 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

    PubMed 29802551

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amrubicin, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Michaela Liedtke at 1 site in United States.

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 26 inclusion and 10 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria (time frame: 12 weeks). 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 NCT01355705, which also lists 1 linked publication.

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 18 Sep 2018.

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