Phase 2
N=18
Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00691704 ↗Enrolled (actual)
18
Serious AEs
22.2%
Results posted
Apr 2014
Primary outcome: Primary: Progression Free Survival — 3; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenalidomide Induction (Drug); Sequential Maintenance Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cristina Gasparetto
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
3; 9 | — |
| SECONDARY Time to Response |
2 | — |
| SECONDARY Overall Survival |
36 | — |
| SECONDARY Time to Progression |
11 | — |
| SECONDARY Duration of Response |
11 | — |
Summary
The purpose of this study is to evaluate the effectiveness of induction therapy with lenalidomide and low dose dexamethasone followed by sequential low dose bortezomib followed by low dose Melphalan and Prednisone, then followed by low dose lenalidomide for multiple cycles in subjects with high risk Multiple Myeloma (MM). The primary objective is to evaluate the efficacy as measured by the progression free survival (PFS) at 2 years of low dose sequential therapy following four cycles of induction therapy with lenalidomide/low-dose dexamethasone in subjects with symptomatic high risk multiple myeloma, who have received no prior treatment. A total of 35 subjects were estimated to be accrued to this Phase II trial over a period of subjects who are still progression-free at 2 years. Two years will be as measured from date of registration to the trial. Progression will include disease progression (DP) as well as death due to any cause. Data will be analyzed and reported by the PI after 1 and 2 years of initiation of the study. All subsequent data collected may be analyzed and reported in a follow-up clinical report. The PI and independent reviewers will meet to review the efficacy and safety data and determine a risk/benefit analysis in this subject population.
Eligibility Criteria
Inclusion Criteria
- Understand and voluntarily sign an informed consent form.
- Age 18 years or older at the time of signing the consent.
- Able to adhere to the study visit schedule and other protocol requirements.
- Multiple myeloma (MM) diagnosed according to the following standard criteria:
- Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma
- Monoclonal protein present in serum and/or urine Myeloma-related organ dysfunction (1 or more) (C) Calcium elevation in blood (serum calcium >10.5 mg/L or ULN) (R) Renal insufficiency (SCr >2 mg/dL) (A) Anemia (hemoglobin /=50 milli-International unit (mIU)/mL within 10-14 days prior to and within 24 hours of prescribing lenalidomide and must use 2 acceptable methods of birth control, one highly effective method and one other effective method AT THE SAME TIME, >4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom even if he has had a successful vasectomy, if partner is FCBP.
- Disease free of prior malignancies for >5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
- Able to take 325 mg aspirin daily as prophylactic anticoagulation for the duration of protocol therapy.
- Receive concomitant therapy with bisphosphonates if bony lesions are present at time of enrollment.
Exclusion criteria
- Any serious medical condition, laboratory abnormality, or psychiatric illness to prevent the subject from signing the consent.
- Pregnant or breast feeding females.
- Any condition which places the subject at unacceptable risk or confounds the ability to interpret data from the study.
- Abnormal laboratory test results within these ranges:
- Absolute neutrophil count 70% bone marrow are eligible)
- Serum creatinine > 2.5 mg/dL or ≥ 3.0 mg/dL if due to multiple myeloma.
- Total bilirubin > 2.0 mg/dl
- History of allergy to any of the study medications, their analogues, or excipients in the various formulations
- Concurrent use of other anti-cancer agents or treatments.
- Known HIV positivity
- Known Active Hepatitis A, B or C
- Erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drug.
Data sourced from ClinicalTrials.gov (NCT00691704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.