NMP : A Phase I, Open Label Dose Escalation Trial of Orally Administered N-methyl-pyrrolidone (NMP) in Patients With Relapsed or Refractory Myeloma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase I trial is evaluating an oral drug (N-methyl-pyrrolidone) in patients with relapsed Myeloma.
 

This trial is treating patients with Multiple Myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase I, Open Label Dose Escalation Trial of Orally Administered N-methyl-pyrrolidone (NMP) in Patients With Relapsed or Refractory Myeloma

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to humans at doses, which induce measurable immunological and anti-tumour effects in patients with myeloma who are resistant to or intolerant of lenalidomide and bortezomib. N‐Methyl‐2‐pyrrolidone (NMP) is a small molecule acetyl‐lysine mimetic compound with potent (low micromolar range) immunomodulatory and direct anti‐myeloma activity attributable to BETbromodomain inhibition at higher concentrations. NMP is nontoxic, stable and already in use as a solvent in biomedical applications. It has been the subject of numerous toxicity studies in humans and been demonstrated to have few adverse effects. The study is proposing an empiric starting dose of 50mg daily, 50% of that seen in healthy volunteers with no observable toxicity. Dose escalation will follow a rule based on accelerated trial design in order to minimise the number of patients treated at sub‐therapeutic doses and minimise the length of the study. During the accelerated dose‐escalation phase, one patient will be entered per cohort with a dose escalation increment of 100%, with up to 6 dose escalation and up to two dose de‐escalation levels.The accelerated phase ends when one patient experiences DLT during the first cycle of treatment or when a total of two patients have experienced moderate toxicity during the first cycle of treatment regardless of the dose level; or the most recent patient has been treated at the highest dose level in the first cycle. If 1 patient experiences a DLT in the first cycle at any dose level, the cohort will be further expanded to a total of 6 patients treated at the same dose level. The maximum tolerated dose (MTD) in the study will be defined as the highest dose in which the incidence of DLT was less than 33%.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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