Multiple Myeloma Clinical Trial
Official title:
An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study)
The study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients with myeloma) will have an acceptable toxicity profile and that in combination will have sufficient activity in the target population (including those previously refractory to HDACi monotherapy) to warrant further investigation.
Summary of rationale:
1. As individual agents, both the histone deacetylase inhibitors and lenalidomide have
significant activity in each of the diseases in this study;
2. There is potential for the agents to synergize (to improve upon the response rates as
there are both overlapping and disparate mechanisms of action.) Both agents may
synergize to induce cell death through caspase 8-mediated and other mechanisms; both
induce p21 and cell cycle arrest; both agents have anti-angiogenic effects; both are
likely to interfere with PI3K/Akt signaling. One particularly attractive aspect of this
combination is the potential for synergistic immunological effects, particularly related
to T-cell polarization, NK cell activation, STAT signaling and cytokine production, as
discussed above;
3. With respect to PTCL, CTCL and HL, there is a clear path for further drug development
and registration if this trial proves that this is a safe and efficacious combination;
4. Myeloma is incurable and this is due to the persistence of a drug-resistant sub-clone of
tumor-propagating cells that is drug insensitive. Preclinical data suggests that both
HDACi and lenalidomide may target these tumor-propagating cells. This argues for
examining this combination as part of early treatment in these diseases. This trial is
the first step to examine the feasibility of combining an HDACi with what is front-line
therapy in myeloma in the USA - lenalidomide.
5. Incorporating three separate arms (as opposed to three separate studies) will allow;
i. The investigators to accumulate data on this novel combination across the three
groups and evaluate the toxicity profiles to make informed decisions around
dose-escalation. Because it is a single study, valid comparisons can be made across the
groups, which would not be possible if they were separate studies.
ii. combined and simplified collection of correlative tests across the three studies.
This study was terminated and Phase 2 portion never was initiated.
;
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