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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. 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.


Inclusion Criteria:



- 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

- 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

Exclusion Criteria:

- 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)

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients experiencing a stringent complete response (sCR) after 12 cycles 24 months

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Craig B. Reeder, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic in Arizona

Authority:

United States: Food and Drug Administration

Study ID:

MC1186

NCT ID:

NCT01706666

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Maintenance
  • Consolidation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Washington University School of MedicineSaint Louis, Missouri  63110
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Baylor Medical CenterGarland, Texas  75042