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Phase I Infusional Cyclophosphamide and Pulse Dexamethasone With Rapamycin and Hydroxychloroquine in Patients With Relapsed or Refactory Myeloma

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

Phase I Infusional Cyclophosphamide and Pulse Dexamethasone With Rapamycin and Hydroxychloroquine in Patients With Relapsed or Refactory Myeloma

Inclusion Criteria:

- Histologically confirmed multiple myeloma

- Documented relapse or persistent disease after at least one prior therapy (which may
include autologous and allogeneic bone marrow transplantation)

- Need for further treatment for myeloma, as determined by the patient's treating

- Age ≥18 years. Both men and women and members of all races and ethnic groups will be

- ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix).

- Ability to understand and the willingness to sign a written informed consent

- Birth control is required with full barrier contraceptives or complete abstinence for
the duration of time receiving therapy and for 6 months after completing the last
drug taken.

- The need for further treatment: This is defined as progression of clinical
features (worsening anemia, renal function, bone disease, hypercalcemia,
recurrent infections, and constitutional symptoms) or biochemical progression
(increasing M-spike in serum or urine, involved serum or urine free light chain
over 2 consecutive time points greater than 4 weeks apart).

Exclusion Criteria:

- History of allergic reactions to compounds of similar chemical or biological
composition to rapamycin or hydroxychloroquine

- Patients may not take any of the following medications while on study, but will be
considered eligible if medication is discontinued at least 72 hrs prior to first dose
of Rapamycin.

- Carbamazepine (e.g. Tegretol)

- Rifabutin (e.g. Mycobutin)

- Rifampin (e.g. Rifadin)

- Rifapentine (e.g. Priftin)

- St. John's Wort

- Clarithromycin (e.g. Biaxin)

- Cyclosporin e.g. (Neorla or Sandimmune)

- Diltiazem (e.g. Cardizem)

- Erythromycin (e.g. Akne-Mycin, Ery-Tab)

- Itraconazole (e.g. Sporonox)

- Fluconazole (e.g. Diflucan)

- Ketoconazole (e.g. Nizoral)

- Telithromycin (e.g. Ketek)

- Verapamil (e.g. Calan SR, Isoptin, Verelan)

- Voriconazole (e.g. VFEND)Tacrolimus (e.g. Prograf)

- Known macular degeneration or retinopathy (diabetic or otherwise), porphyria, or
psoriasis (well-controlled psoriasis allowed provided under the care of a specialist
who agrees to monitor the patient for exacerbations)

- Patients with the following cytopenias:

- ANC <1.0 x 109/L;

- Platelets < 50 x 109/L for any reason

- Patients with the following chemistry abnormalities:

- Serum Creatinine > 2.5 mg/dL;

- Total or Direct Bilirubin > 2.0 mg/dL;

- Transaminases 2 x the upper limit of normal

- Fasting Glucose > 200mg/dL

- Serum potassium < 3.4 mmol/l

- Serum phosphorus < 2.4mg/dl

- Other conditions that would require therapy with hydroxychloroquine, including but
not limited to, any of the following:

- Systemic lupus

- Rheumatoid arthritis

- Porphyria cutanea tarda

- Malaria treatment or prophylaxis

- Evidence of other active malignancy, except:

- Basal cell or squamous cell carcinoma of the skin

- Treated carcinoma in situ

- Uncontrolled intercurrent illness including, but not limited to, any of the

- Uncontrolled ongoing infection


- Hepatitis B infection

- Known G6PD deficiency

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Uncontrolled cardiac arrhythmia

- Psychiatric illness or social situations that would limit compliance with study

- Active GvHD

- Inability to understand or unwillingness to sign the informed consent document

- Concurrent anti-myeloma therapy within:

- 7 days of prior corticosteroids

- 14 days of prior antimyeloma agents, including thalidomide or lenalidomide

- 28 days of a different investigational regimen

- 14 days of any radiation

- Women of child-bearing who are unwilling or unable to use an acceptable method to
avoid pregnancy for the entire study period and for up to 30 days after the last dose
of study drug.

- Women who are pregnant or breastfeeding.

- History of G6PD deficiency

- HIV infection

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Maximum tolerated dose (MTD)of Hydroxychloroquine (HCQ),Rapamycin, Dexamethasone, and Cyclophosphamide.

Outcome Description:

To determine the maximum tolerated dose (MTD) of hydroxychloroquine (HCQ) in combination with rapamycin and infusional cyclophosphamide and pulse dexamethasone (cy/dex) for patients with relapsed/ refractory multiple myeloma.

Outcome Time Frame:

Duration of the study; up to 2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



OHSU Knight Cancer Institute Portland, Oregon  97239