AzTrials
AzTrials

Stage I Multiple MyelomaPhase 2NCT01706666

Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant

A Phase 2 study testing bortezomib, cyclophosphamide and lenalidomide in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by Mayo Clinic at 4 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, cyclophosphamide and lenalidomide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
4 sitesUnited States
Study dates
7 Dec 2012to 17 May 2016
Phase
Phase 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

  • Creatinine =< 2 mg/dL
  • Absolute neutrophil count (ANC) >= 1000/mm^3
  • Platelet count >= 75000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Treated myeloma: Prior induction therapy (any) and followed by autologous stem cell transplantation
Show all 24Show fewer
  • Measurable disease at initial diagnosis, pre-stem cell transplant (SCT) or post-SCT of multiple myeloma as defined by at least ONE of the following:
  • Serum monoclonal protein >= 0.5 g/dL
  • > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
  • Serum immunoglobulin free light chain >= 5 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • < 120 days post SCT with no evidence of relapse or progression prior to registration
  • Provide voluntary informed written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Willing to return to enrolling institution for follow-up during the active monitoring phase of the study
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Female patients who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse
  • Male patients, even if surgically sterilized (ie, status postvasectomy), who:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment, OR
  • Agree to completely abstain from heterosexual intercourse

Who cannot join

  • Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
  • Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
  • Known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus positive (HBV+)
  • Hypersensitivity to study drugs, boron or mannitol
  • Patient refractory to bortezomib (defined as patients who progressed while on bortezomib or within 60 days of receiving bortezomib)
Show all 12Show fewer
  • Any serious medical or psychiatric condition that would prevent the subject from complying with the protocol treatment and procedures
  • Grade >= 2 peripheral neuropathy
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial
  • Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy
  • Female patients who are lactating or pregnant

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

  • Baylor Medical Center

    Garland, Texas, 75042

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma

This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the stringent complete response (sCR) rate after 12 cycles among arms.

SECONDARY OBJECTIVES:

  1. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm.

TERTIARY OBJECTIVES:

  1. To compare sCR after 6 cycles and 24 cycles and quality of life among arms.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.

ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28.

In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Being tested
bortezomib, cyclophosphamide, lenalidomide, laboratory biomarker analysis, dexamethasone
Keywords
Maintenance, Consolidation
Medical subject headings
Multiple Myeloma

What participants receive

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

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given SC

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given PO

  • lenalidomideDrug

    Also called CC-5013, IMiD-1, Revlimid

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • dexamethasoneDrug

    Also called Aeroseb-Dex, Decaderm, Decadron, DM

    Given PO

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT01706666
Study groupRoleWhat they receive
Arm A (bortezomib)ExperimentalPatients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Receives: Drug: bortezomib; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment
Arm B (bortezomib, cyclophosphamide, dexamethasone)ExperimentalPatients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
Receives: Drug: bortezomib; Drug: cyclophosphamide; Other: laboratory biomarker analysis; Drug: dexamethasone; Procedure: quality-of-life assessment
Arm C (bortezomib, lenalidomide)ExperimentalPatients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
Receives: Drug: bortezomib; Drug: lenalidomide; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment

What is being measured

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

  1. Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months

    Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.

    Measured: 24 months

Secondary outcomes (2)

  1. Survival Time

    The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.

    Measured: From registration to death due to any cause, assessed up to 3 years

  2. Progression-free Survival

    The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.

    Measured: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years

Timeline

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

  1. First posted15 Oct 2012 (estimated)
  2. Study start7 Dec 2012
  3. Primary completion10 Jul 2014
  4. Study completion17 May 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706666
Sponsor's protocol ID
MC1186
Other IDs
NCI-2012-01579
Status last verified
Aug 2018
First submitted
11 Oct 2012
Last updated
17 Sep 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib, cyclophosphamide and lenalidomide in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by Mayo Clinic at 4 sites 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 24 inclusion and 12 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 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 4 sites 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 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?

Yes. Results are posted in the registry (first posted 3 Jun 2016). 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?

Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months (time frame: 24 months). 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 NCT01706666.

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 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in