Phase 2
N=50
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01782963 ↗Enrolled (actual)
50
Serious AEs
68.0%
Results posted
Mar 2018
Primary outcome: Primary: Objective Response Rate — 6; 16; 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenalidomide (Drug); Bortezomib (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
6; 16; 11; 10 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Treatment Related Adverse Events |
8; 1; 17; 7; 0; 1 | — |
| SECONDARY Median Progression Free Survival |
35.1 | — |
| SECONDARY Median Overall Survival |
NA | — |
| SECONDARY Median Time to Response |
1.1 | — |
| SECONDARY Response Rate With Respect to Cytogenetic Characteristics |
0; 6; 2; 14; 2; 9 | — |
| SECONDARY Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection |
98.84; 13; 8.73; 20.5; 1.82; 1.96 | — |
| SECONDARY Pharmacogenomic Markers of Neuropathy |
— | — |
Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.
Eligibility Criteria
Inclusion Criteria
- Documented symptomatic myeloma, with organ damage related to myeloma
- Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
- Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method
Exclusion Criteria
- Eligible for autologous stem cell transplantation
- HIV positive on combination antiretroviral therapy
- Pregnant or breastfeeding
- Treated with any prior systemic therapy
- Primary amyloidosis or myeloma complicated by amyloidosis
- Receiving other investigational agents within 14 days of the start of this trial or during this trial
- Known brain metastases
- Poor tolerability or known allergy to any of the study drugs or similar compounds
- Intercurrent illness
- Previous history of another malignant condition except for basal cell carcinoma or stage I cervical cancer
- Inability to comply with an anti-thrombotic treatment regimen
- Peripheral neuropathy greater than or equal to grade 2
Data sourced from ClinicalTrials.gov (NCT01782963). 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.