Phase II Subcutaneous VELCADE and Oral Cyclophosphamide-based Induction + Sequential VELCADE and Revlimid Maintenance for Newly Diagnosed Multiple Myeloma in Non-transplant Candidates: An Entirely Non-intravenous Regimen
- Voluntary written informed 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not part of normal medical care, with the understanding that consent may be withdrawn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.
- Age ≥18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- MM diagnosed according to the following standard criteria (all three criteria must be
- Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven
- Laboratory tests meet the levels specified in the protocol
- Measurable disease requiring systemic therapy.
- No prior systemic therapy or radiation therapy active against myeloma lasting more
than four weeks duration. Any prior therapy must be completed a minimum of 21 days
before starting study drugs. Enrollment of subjects who require 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.
- Karnofsky performance status (KPS) of ≥ 60% at study entry.
- In order to obtain lenalidomide, patients must be registered into the mandatory
RevAssist® program during the maintenance phase of therapy, and be willing and able
to comply with the requirements of RevAssist®.
- Female subjects must be postmenopausal for at least 1 year before the screening visit
or surgically sterilized. If females are of childbearing potential, they must adhere
to required pregnancy testing; male and female subjects must use specified effective
birth control methods.
- Patients should receive concomitant therapy with bisphosphonates, regardless of the
presence of bony lesions, although study physicians may use their discretion based on
presence of renal insufficiency or other mitigating factors.
- Abnormal laboratory tests within the ranges specified in the protocol
- Serum creatinine will not be used to exclude patients. Patients on renal-replacement
therapy (e.g., hemodialysis or peritoneal dialysis) will be eligible to participate.
- Light-chain (AL) amyloidosis. Patients with secondary amyloidosis due to MM are
- ≥ 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 (see Appendix 7.7), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry,
any ECG abnormality at screening must be documented by the investigator as not
- Hypersensitivity to VELCADE, boron, mannitol, or any other component of protocol
- Female subject is pregnant or lactating. Confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(b- hCG) pregnancy test result obtained during screening as specified in section
- Female patients who are lactating or have a positive serum pregnancy test during the
screening period, or a positive urine pregnancy test on Day 1 before first dose of
study drug, if applicable.
- Serious medical or psychiatric illness likely to interfere with participation in this
- Diagnosed or treated for another malignancy within 2 years of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- 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
- Concurrent use of other anti-cancer agents or treatments
- Known HIV positivity
- Known active hepatitis A, B or C